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Chronic wounds, characterized by prolonged healing processes, pose a significant medical challenge with multifaceted aetiologies, including local and systemic factors. Here, it explores the complex pathogenesis of chronic wounds, emphasizing the disruption in the normal phases of wound healing, particularly the inflammatory phase, leading to an imbalance in extracellular matrix (ECM) dynamics and persistent inflammation. Senescent cell populations further contribute to impaired wound healing in chronic lesions. Traditional medical management focuses on addressing underlying causes, but many chronic wounds resist to conventional treatments, necessitating innovative approaches. Recent attention has turned to autologous orthobiologics, such as platelet-rich plasma (PRP), platelet-rich fibrin (PRF) and mesenchymal stem cells (MSCs), as potential regenerative interventions. These biologically derived materials, including bone marrow aspirate/concentrate (BMA/BMAC) and adipose tissue-derived stem cells (ADSCs), exhibit promising cytokine content and regenerative potential. MSCs, in particular, have emerged as key players in wound healing, influencing inflammation and promoting tissue regeneration. This paper reviews relevant scientific literature regarding basic science and brings real-world evidence regarding the use of orthobiologics in the treatment of chronic wounds, irrespective of aetiology. The discussion highlights the regenerative properties of PRP, PRF, BMA, BMAC and SVF, showcasing their potential to enhance wound healing. Despite advancements, further research is essential to elucidate the specific roles of each orthobiologic and determine optimal applications for different wound types. The conclusion underscores the evolving landscape in chronic wound management, with a call for more comprehensive studies to refine treatment strategies and maximize the benefits of regenerative medicine.
As the incidence of diabetic foot ulcers (DFU) increases, better treatments that improve healing should reduce complications of these ulcers including infections and amputations. We conducted a randomized controlled trial comparing outcomes between a novel purified reconstituted bilayer membrane (PRBM) to the standard of care (SOC) in the treatment of non-healing DFUs. This study included 105 patients who were randomized to either of two treatment groups (n = 54 PRBM; n = 51 SOC) in the intent to treat (ITT) group and 80 who completed the study per protocol (PP) (n = 47 PRBM; n = 33 SOC). The primary endpoint was the percentage of wounds closed after 12 weeks. Secondary outcomes included percent area reduction, time to healing, quality of life, and cost to closure. The DFUs that had been treated with PRBM healed at a higher rate than those treated with SOC (ITT: 83% vs. 45%, p = 0.00004, PP: 92% vs. 67%, p = 0.005). Wounds treated with PRBM also healed significantly faster than those treated with SOC with a mean of 42 versus 62 days for SOC (p = 0.00074) and achieved a mean wound area reduction within 12 weeks of 94% versus 51% for SOC (p = 0.0023). There were no adverse events or serious adverse events that were related to either the PRBM or the SOC. In comparison to the SOC, DFUs healed faster when treated with PRBM. Thus, the use of this PRBM is an effective option for the treatment of chronic DFUs.
Oral mucosa is an ideal model for studying scarless wound healing. Researchers have shown that the key factors which promote scarless wound healing already exist in basal state of oral mucosa. Thus, to identify the other potential factors in basal state of oral mucosa will benefit to skin wound healing. In this study, we identified eight gene modules enriched in wound healing stages of human skin and oral mucosa through co-expression analysis, among which the module M8 was only module enriched in basal state of oral mucosa, indicating that the genes in module M8 may have key factors mediating scarless wound healing. Through bioinformatic analysis of genes in module M8, we found IGF2 may be the key factor mediating scarless wound healing of oral mucosa. Then, we purified IGF2 protein by prokaryotic expression, and we found that IGF2 could promote the proliferation and migration of HaCaT cells. Moreover, IGF2 promoted wound re-epithelialization and accelerated wound healing in a full-thickness skin wound model. Our findings identified IGF2 as a factor to promote skin wound healing which provide a potential target for wound healing therapy in clinic.
To explore the role of nutritional support in nursing practice on postoperative surgical site wound healing in patients undergoing surgery at risk for pressure ulcers. This study adopted a retrospective experimental design and included a total of 60 patients at risk of pressure ulcers, divided into a nutritional support group and a control group, with 30 people in each group. The nutritional support group implemented specific nutritional support measures after surgery, while the control group received standard postoperative care. Outcome measures included redness and swelling scores, edema scores, anxiety assessments, pain scores, bleeding volume, recovery time and incidence of pressure ulcers. The result indicates that patients who received nutritional support exhibited lower postoperative wound redness and swelling scores compared to the control group (3.11 ± 0.45 vs. 4.85 ± 0.74, p < 0.05). Additionally, the nutritional support group showed significantly lower edema scores (2.75 ± 0.37 vs. 3.53 ± 0.62, p < 0.05). Anxiety levels, as measured by the anxiety assessment scale (SAS), were also lower in the nutritional support group (6.52 ± 1.19 vs. 7.60 ± 1.62, p < 0.05). Moreover, the average healing time was shorter for the nutritional support group (7.27 ± 1.36 days) compared to the control group (9.71 ± 1.84 days, p < 0.05). Postoperative pain scores were lower in the nutritional support group (4.13 ± 0.72 vs. 5.43 ± 0.62, p < 0.05), and patient satisfaction scores were higher (9.42 ± 0.76 vs. 7.25 ± 0.81, p < 0.05). Nutritional support has a positive effect on postoperative wound healing at surgical sites in patients at risk of pressure ulcers in nursing practice. It can significantly reduce redness, swelling, edema, anxiety, and pain scores, reduce bleeding, shorten recovery time, and reduce pressure ulcers. incidence rate.
Clinical studies indicate antibiotic bone cement with propeller flaps improves diabetic foot wound repair and reduces amputation rates, but the molecular mechanisms, particularly key proteins' role remain largely unexplored. This study assessed the efficacy of antibiotic bone cement for treating diabetic foot wounds, focusing on molecular impact on ROCK1. Sixty patients were randomized into experimental (EXP, n = 40) and control (CON, n = 20) groups, treated with antibiotic bone cement and negative pressure. Wound healing rate, amputation rate, wound secretion culture and C-reactive protein (CRP) changes, were monitored. Comprehensive molecular investigations were conducted and animal experiments were performed to further validate the findings. Statistical methods were employed to verify significant differences between the groups and treatment outcomes. The EXP group showed significant improvements in wound healing (χ2$$ {\chi}^2 $$ = 11.265, p = 0.004) and reduced amputation rates. Elevated levels of ROCK1, fibroblasts and VGF were observed in the trauma tissue post-treatment in the experimental group compared to pre-treatment and the control group (all p < 0.05). Improved trauma secretion culture and CRP were also noted in the EXP group (all p < 0.05). The study suggests that antibiotic bone cement enhances diabetic foot wound healing, possibly via upregulation of ROCK1. Further research is needed to elucidate the underlying molecular mechanisms and broader clinical implications.
We evaluated the primary application of crushed prednisolone combined with hydrocolloid powder for clinically diagnosed peristomal pyoderma gangrenosum (PPG). We present our data on this cohort and follow-up of our previous patients. Of the 23 patients who were commenced on this regime, 18 healed (78%). Twenty-two patients commenced on this regime as the primary treatment for their PPG, and for one, it was a rescue remedy after failed conventional therapy. Four patients with significant medical comorbidities failed to heal and one had their stomal reversal surgery before being fully healed. The proposed treatment regime for PPG is demonstrated to be effective, inexpensive and able to be managed in the patient's usual home environment. In vitro drug release analysis was undertaken, and data are presented to provide further insights into the efficacy of this regime.
Burn survivors experience profound physiological changes following injury, which may have lasting implications for cardiovascular health. This study aims to investigate the cardiovascular risk profile among burn survivors treated at a burn center in northern Iran. This observational study was conducted from 2022 to 2023 at the burn centre affiliated with Guilan University of Medical Sciences, Rasht, Iran. This study assessed a cohort study of 210 burn survivors, focusing on individuals with ≥20% TBSA burn injuries who had recovered and returned to their daily lives. This study assessed patients' lipid profiles, Framingham General Cardiovascular Risk Score (FGCRS) and risk factors, including demographics, clinical variables and physical activity. Statistical analysis employed descriptive and inferential statistics. The mean age was 49.23 years, and the mean TBSA burned was 37.06%. The risk of cardiovascular disease in 66% of the study population was less than 10%, and in 13%, it was more than 20%. Significant associations were identified between CVD risk and sex, diabetes, hypertension, BMI, TBSA burned, years after burn, physical activity level and LDL. Of the lipid profile measures, LDL, triglycerides and TC/HDL exceeded the desirable levels. This research highlights the heightened cardiovascular risk in burn survivors, emphasizing the necessity for targeted interventions and regular monitoring. Identifying modifiable risk factors enables healthcare practitioners to develop tailored strategies, enhancing cardiovascular health in this vulnerable population and improving overall outcomes and quality of life.
Safe and effective arteriovenous fistula (AVF) puncture is very important to reduce the wound complications of haemodialysis (HD). For AVF puncture in dialysis patients, there is a lack of clarity and consistency regarding the relative advantage of buttonhole (BH) over rope-ladder (RL) cannulae in terms of wound complications. The study was published in several scientific databases including Cochrane Library, PubMed and Embase by October 2023. Data from all controlled trials looking at the effect of BH and RL on wound complications in haemodialysis patients were included. The articles were written in English, and they were about adult who had AVF while on dialysis. Studies with or without BH or RL treatment were excluded from the analysis. The data was analysed with RevMan5.3 software. Out of 215 trials, 9 were chosen for the final analysis. The study publication dates were between 2000 and 2023. Of these, 17 326 patients received AVF therapy. Among them, there were 3070 BH and 14 256 RL. In 9 studies, RL had a lower risk of postoperative wound infection compared to BH (OR, 3.38; 95% CI, 3.06, 3.73 p < 0.0001); In all 3 studies, there were no statistically significant differences in the risk of post operative bleeding in RL versus BH(OR, 0.76; 95% CI, 0.25, 2.33 p = 0.63). Our studies have demonstrated that RL trocars are superior to BH trocars in the prevention of wound infection.
In the ongoing challenge to reduce burn-associated mortality rates, this study explores the predictive capacity of clinical factors in burn patients, focusing on vitamin D, calcium, and serum albumin levels during hospitalisation in cases with Pseudomonas aeruginosa infection. Our research involves a comprehensive analysis of 100 burn patients, encompassing crucial clinical parameters such as the burn severity index, serum albumin, vitamin D, and calcium levels at admission. Data were meticulously entered into IBM Statistics SPSS software version 28 and subjected to statistical analysis. The study reveals an average patient age of 39.75 years and a notable 34% mortality rate. Additionally, the average lengths of hospital and intensive care unit (ICU) stays are determined to be 11.33 and 7.79 days, respectively. Significantly, a correlation between calcium and albumin variables and treatment outcomes is established, showcasing their potential to predict variable changes in patient mortality rates. Furthermore, a noteworthy association is observed between serum calcium levels and the duration of ICU hospitalisation. In conclusion, albumin and calcium variables emerge as sensitive and specific indicators for predicting outcomes in burn patients. Importantly, the independence of these factors from the physician's experience and diagnosis reduces human error and thus increases the accuracy of mortality prediction in this patient population.
Cleansing is a vital component of effective wound hygiene and biofilm management, often accomplished through vigorous mechanical action or through soaking with moistened gauze. In the present study, a quantitative comparison of the effectiveness of different cleansing techniques and solutions in removing bacteria was conducted on 71 chronic wounds using bacterial fluorescence imaging as a real-time diagnostic for moderate to high bacterial loads. Vigorous gauze cleansing for 30 s proved most effective by reducing bacterial fluorescence by 33.99%, surpassing 10-min soaking in bacterial reduction (13.24%). Among different cleansers, no statistically significant differences in effectiveness were observed, but povidone-iodine showed the strongest trend towards bacterial reduction. Sub-analysis highlighted the superiority of antiseptic cleansers over saline and gentle soap (−33.30% vs. −1.80% bacterial reduction respectively). Five percent acetic acid was also shown to be more effective in removing specific bacterial strains (Pseudomonas aeruginosa). Findings from studies like this contribute to refining wound hygiene guidelines and clinical algorithms for bacterial and biofilm management.
Evaluating complications and mortality risks in burn patients is crucial for effective treatment planning and improving survival rates. This study investigated the relationship between the serum vitamin D level and the clinical outcomes of adult burns patients. This was a prospective cohort of adult patients hospitalized due to thermal burns at a burn centre in the north of Iran. Based on the level of 25 hydroxyvitamin D measured upon admission, patients were divided into two groups of patients with sufficient 25 hydroxyvitamin D level and insufficient 25 hydroxyvitamin D level. Descriptive statistics were used for baseline demographics. Univariate analysis was conducted using Mann–Whitney U, Chi-square, independent samples, and Fisher's exact tests. A multivariate logistic regression was performed to adjust for the effects of confounding variables. Statistical analyses were conducted using SPSS 28.0 software. A total of 220 patients were included in the study. The average total body surface area burned was 30.52 ± 9.34. Patients with insufficient vitamin D levels had longer hospital stays (12.53 vs. 11.45) and longer stays in the intensive care unit (ICU) (3.32 vs. 2.40) than those with appropriate vitamin D levels. Participants with insufficient vitamin D levels exhibited a numerically higher incidence of infections than those with adequate levels (p < 0.05). The multivariate regression found that vitamin D deficiency levels were associated with increased infection rates and prolonged hospital stay. This study suggests that vitamin D deficiency is a significant risk factor for adverse clinical outcomes in burn patients. Further research is needed to confirm these associations and to explore potential interventions to optimize vitamin D status in this patient population.
This meta-analysis assesses the impact of Enhanced Recovery After Surgery (ERAS) protocols on surgical site wound infections (SSWIs) in urological procedures. Analysing data from 10 studies, our focus was on SSWI rates on the third and seventh postoperative days. The results reveal a significant reduction in SSWI rates for patients managed under ERAS protocols compared with traditional care. Notably, Figure 4 demonstrates a substantial decrease in SSWI on the third day (I 2 = 93%; random: standardized mean difference [SMD]: −6.25, 95% confidence interval [CI]: −7.42 to −5.05, p < 0.01), and Figure 5 mirrors this trend on the seventh day (I 2 = 95%; random: SMD: −4.72, 95% CI: −6.28 to −3.16, p < 0.01). These findings underscore the effectiveness of ERAS protocols in minimizing early postoperative wound infections, emphasizing their importance for broader implementation in urological surgeries.
In this article, we analysed the therapeutic efficacy of open radical prostatectomy (ORP) and minimally invasive surgery (MIS) after operation for the treatment of post-operation complications. In summary, because of the broad methodology of the available trials and the low number of trials, the data were limited. The investigators combined the results of six of the 211 original studies. We looked up 4 databases: PubMed, EMBASE, Web of Science and the Cochrane Library. A total of six publications were selected. The main result was the rate of post-operation wound complications. Secondary results were the time of operation and the duration of hospitalization. Our findings indicate that the minimal invasive operation can decrease the incidence of wound infections (OR, 0.61; 95% CI: 0.42,0.90, p = 0.01), bleeding (MD, −293.09; 95% CI: −431.48, −154.71, p < 0.0001), and length of stay in the hospital compared with open surgery (MD, −1.85; 95% CI: −3.52, −0.17, p = 0.03), but minimally invasive surgery increased patient operative time (MD, 51.45; 95% CI: 40.99, 61.92, p < 0.0001). Compared with the open operation, the microinvasive operation has the superiority in the treatment of the wound complications following the operation of radical prostatic carcinoma. But the operation time of the microinvasive operation is much longer. Furthermore, there is a certain amount of bias among the various studies, so it is important to be cautious in interpretation of the findings.
This study aims to (1) characterize healthcare professionals' (HCPs') experiences related to the prevention and management of pressure injuries (PIs) and (2) explore the educational needs of individuals with a past or current history of PIs and their caregivers from the perspective of HCPs. This is a qualitative descriptive study. HCPs (n = 18) were interviewed using a semi-structured interview guide. Interviews were audio-recorded, transcribed verbatim and coded using NVivo. Three overarching themes encompassing various dimensions were identified: (1) Facilitators related to PI prevention and management, (2) Challenges related to PI prevention and management and (3) Recommendations for improving patient and caregiver PI education. HCPs identified a greater number of challenges than facilitators related to PI care. This study emphasizes the importance of a patient-centred and interprofessional approach to patient education for PI prevention and management. Meaningful interventions focused on the patient may improve health literacy and empower patients and caregivers in PI care. Investing in preventive measures and raising awareness are crucial to reducing PI incidence. The findings have implications for HCPs and researchers seeking to enhance patient care and promote effective PI prevention strategies.
This systematic review and meta-analysis aimed to evaluate the relationship between body mass index (BMI) and mortality of burn patients. A comprehensive, systematic search was conducted in different international electronic databases, such as Scopus, PubMed, Web of Science and Persian electronic databases such as Iranmedex, and Scientific Information Database (SID) using keywords extracted from Medical Subject Headings such as “Body mass index”, “Burns” and “Mortality” from the earliest to the April 1, 2023. The quality of the studies included in this systematic review was evaluated using the appraisal tool for cross-sectional studies (AXIS tool). Finally, six articles were included in this systematic review and meta-analysis. A total of 16 154 burn patients participated in six studies. Their mean age was 46.32 (SD = 1.99). Of the participants, 71.7% were males. The mean length of hospitalization was 18.80 (SD = 8.08) days, and the average TBSA in burn patients was 38.32 (SD = 2.79) %. Also, the average BMI in burn patients was 27.10 (SD = 1.75). Results found mortality in patients with abnormal BMI (overweight to morbidity BMI) was 0.19 more than normal BMI (ES: 1.19, 95%CI: 0.76–1.87, Z = 0.75, I 2: 71.8%, p = 0.45). Results of linear dose–response showed each 5 kg/m2 increase in BMI was associated with a 5% increase in mortality that was marginally significant (ES: 1.05, 95%CI: 1.00–1.11, Z = 1.99, I 2: 22.2%, p = 0.047). There was a non-linear relationship between levels of BMI and mortality (Prob > χ 2 = 0.02). There was an increase in mortality from percentile 10 to 50, although it was not significant (Correlational coefficient: 0.01, p = 0.85). Also, there was an increase in mortality rate from percentile 50 to 90 that was statistically significant (correlational coefficient: 0.06, p = 0.047). Finally, the results of the study indicated BMI can increase the chance of mortality by 0.19, although it was not significant. As a result, more studies are needed to better judge the relationship between BMI and mortality in burn victims.
The primary objective of this study is to examine the efficiency of various regenerative medicine approaches, such as platelet-rich plasma, cell therapy, stromal vascular fraction, exosomes and stem cell-conditioned medium, in the process of healing hypertrophic and keloid scars. Major databases including PubMed, Scopus and Web of Science were systematically searched, and based on the content of the articles and the inclusion and exclusion criteria, eight articles were selected. Out of these eight articles, there were two non-randomized clinical trial studies (25%), one randomized, single-blinded comparative study (12.5%), one retrospective clinical observational study (12.5%) and four randomized clinical trial studies (50%). We employed EndNote X8 and Google Sheets to conduct article reviews and extract relevant data. Following the review phase, the studies underwent analysis and categorization. In all eight reviewed studies, the effectiveness of regenerative medicine in treating hypertrophic scars and keloids has been proven. Out of these studies, five (62.5%) focused on the effectiveness of platelet-rich plasma, two study (25%) examined the effectiveness of stromal vascular fraction and one study (12.5%) explored the efficacy of stem cell-conditioned medium. In two studies (25%), the treatment methods were added to standard treatment, while in six studies (75%), regenerative medicine was used as the sole treatment method and compared with standard treatment. The use of these treatment methods did not result in any serious side effects for the patients. Regenerative medicine is an effective method with minimal side effects for the treatment of hypertrophic scars and keloids. It can be used as a monotherapy or in combination with other treatment methods. However, further studies are needed to thoroughly evaluate the effectiveness of all sub-branches of this method.
A meta-analysis investigation was carried out to measure the wound infections (WIs) and other postoperative problems (PPs) of distal gastrectomy (DG) compared with total gastrectomy (TG) for gastric cancer (GC). A comprehensive literature investigation till February 2023 was used and 1247 interrelated investigations were reviewed. The 12 chosen investigations enclosed 2896 individuals with GC in the chosen investigations' starting point, 1375 of them were TG, and 1521 were DG. Odds ratio (OR) in addition to 95% confidence intervals (CIs) were utilized to compute the value of the WIs and other PPs of DG compared with TG for GC by the dichotomous approaches and a fixed or random model. TG had significantly higher overall PP (OR, 1.58; 95% CI, 1.15–2.18, p = 0.005), WIs (OR, 1.69; 95% CI, 1.07–2.67, p = 0.02), peritoneal abscess (PA) (OR, 2.99; 95% CI, 1.67–5.36, p < 0.001), anastomotic leakage (AL) (OR, 1.90; 95% CI, 1.21–2.97, p = 0.005) and death (OR, 2.26; 95% CI, 1.17–4.37, p = 0.02) compared to those with DG in individuals with GC. TG had significantly higher overall PP, WIs, PA, AL and death compared to those with DG in individuals with GC. However, care must be exercised when dealing with its values because of the low sample size of some of the nominated investigations for the meta-analysis.
This was a non-blinded, single-centre, randomized, controlled clinical trial that compared the effectiveness of direct observation of procedural skills (DOPSs)with traditional assessment methods in pressure injury (PI) care skills. The study population included 82 nursing professionals randomly assigned to the study group (n = 41) and the control group (n = 41). Both groups of nurses underwent a 6-month training in PI care skills and were subsequently evaluated. The main outcome variables were the PI skill operation scores and theoretical scores. Secondary outcome variables included satisfaction and critical thinking abilities. Independent sample t-tests and chi-square tests were used to assess differences between the two groups of nurses. The results showed no statistically significant difference in PI skill operation scores between the two groups of nurses (p > 0.05). When comparing the PI theoretical scores, the study group scored higher than the control group, and this difference was statistically significant (p < 0.05). In terms of satisfaction assessment, the study group and the control group showed differences in improving self-directed learning, enhancing communication skills with patients, improving learning outcomes and increasing flexibility in clinical application (p < 0.05). When comparing critical thinking abilities between the two groups of nurses, there was no statistically significant difference at the beginning of the training, but after 3 months following the training, there was a statistically significant difference between the two groups (p < 0.01).The results indicated that the DOPS was effective in improving PI theoretical scores, increasing nurse satisfaction with the training and enhancing critical thinking abilities among nurses.
The Wound-QoL assesses the impact of chronic wounds on patients' health-related quality of life (HRQoL). A 17-item and a shortened 14-item version are available. The Wound-QoL-17 has been validated for multiple languages. For the Wound-QoL-14, psychometric properties beyond internal consistency were lacking. We aimed to validate both Wound-QoL versions for international samples representing a broad range of European countries, including countries for which validation data had yet been pending. Patients with chronic wounds of any aetiology or location were recruited in Austria, Lithuania, the Netherlands, Poland, Slovakia, Spain, Switzerland and Ukraine. Psychometric properties were determined for both Wound-QoL versions for the overall sample and, if feasible, country-wise. We included 305 patients (age 68.5 years; 52.8% males). Internal consistency was high in both Wound-QoL-17 (Cronbach's α: 0.820–0.933) and Wound-QoL-14 (0.779–0.925). Test–retest reliability was moderate to good (intraclass correlation coefficient: 0.618–0.808). For Wound-QoL-17 and Wound-QoL-14, convergent validity analyses showed highest correlations with global HRQoL rating (r = 0.765; r = 0.751) and DLQI total score (r = 0.684; r = 0.681). Regarding clinical data, correlations were largest with odour (r = −0.371; r = −0.388) and wound size (r = 0.381; r = 0.383). Country-wise results were similar. Both Wound-QoL versions are valid to assess HRQoL of patients with chronic wounds. Due to its psychometric properties and brevity, the Wound-QoL-14 might be preferrable in clinical practice where time is rare. The availability of various language versions allows for the use of this questionnaire in international studies and in clinical practice when foreign language patients are being treated.
A novel autologous heterogeneous skin construct (AHSC) was previously shown to be effective versus standard of care (SOC) treatment in facilitating complete wound healing of Wagner 1 diabetic foot ulcers in an interim analysis of 50 patients previously published. We now report the final analysis of 100 patients (50 per group), which further supports the interim analysis findings. Forty-five subjects in the AHSC treatment group received only one application of the autologous heterogeneous skin construct, and five received two applications. For the primary endpoint at 12 weeks, there were significantly more diabetic wounds closed in the AHSC treatment group (35/50, 70%) than in the SOC control group (17/50, 34%) (p = 0.00032). A significant difference in percentage area reduction between groups was also demonstrated over 8 weeks (p = 0.009). Forty-nine subjects experienced 148 adverse events: 66 occurred in 21 subjects (42%) in the AHSC treatment group versus 82 in 28 SOC control group subjects (56.0%). Eight subjects were withdrawn due to serious adverse events. Autologous heterogeneous skin construct was shown to be an effective adjunctive therapy for healing Wagner 1 diabetic foot ulcers.
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