Conectar
The management of diabetic foot ulcers in patients with peripheral artery disease remains challenging. Human placenta-derived cells (PDA-002), a mesenchymal stromal cell-like population obtained from full-term placental tissue, possess angiogenic and tissue regenerative properties. Participants were stratified based on peripheral artery disease status. A total of 159 individuals were randomly assigned to receive intramuscular PDA-002 at one of three doses (3 × 106, 10 × 106 and 30 × 106 cells) or a placebo. This Phase 2 multi-center, randomised, double-blind, placebo-controlled trial evaluated adults with chronic diabetic foot ulcers with and without peripheral artery disease. The primary efficacy endpoint was the proportion of participants achieving complete wound closure of the index ulcer within 3 months, with sustained closure maintained for an additional 4 weeks. PDA-002 was well-tolerated, with no treatment-related serious adverse events. Intramuscular PDA-002 treatment achieved the highest efficacy at the 3 × 106 cell dose within the peripheral artery disease subgroup (38.5% vs. 22.6% for placebo), meeting a stringent 4-week durability endpoint that surpassed the U.S. Food and Drug Administration's recommended 2-week sustainability criterion. PDA-002 shows promise as a breakthrough treatment for diabetic foot ulcers and peripheral artery disease, demonstrating efficacy with two intramuscular doses and no re-treatment.
Trial Registration: ClinicalTrials.gov identifier: NCT # 02264288
Using a 6-week porcine full-thickness excisional wound grafting model, we evaluated the Autologous Regeneration of Tissue (ART®) System, a novel skin harvesting device designed to collect autologous full-thickness autologous microcolumns (FTAM) at 0.5 mm in diameter. The donor skin sites were harvested using the ART® System and compared to split-thickness skin grafts (STSGs). Recipient sites were divided into three treatment groups: FTAM, STSG and Untreated control. Comparing the FTAM donor sites to the STSG donor sites, we observed significantly faster re-epithelization by Day 4 (p < 0.05), earlier adnexal structures and rete ridge formation by Week 3, and increased collagen and elastin content by Week 6. We also observed an increased rate of healing at the FTAM donor site whilst limiting donor site morbidity compared to traditional STSG donor sites. Time to recipient site closure was 2.4 weeks for STSG treated, 3.3 weeks for FTAM treated and 4.1 weeks for the Untreated control (p < 0.05). The STSG and FTAM recipient sites reached complete re-epithelialization by Weeks 4 and 5, respectively which was significantly faster compared to the Untreated control. However, the FTAM recipient site received only 10% of the donor site tissue relative to the recipient site area and the amount of donor site tissue grafted on the STSG recipient sites was 5× more than the FTAM recipient sites. Additionally, the FTAMs harvested by the ART® System augmented recipient wound site healing as a result of ‘epithelial island’ expansion in contrast to Untreated control sites that closed primarily by contracture.
Ankle Brachial Pressure Index (ABPI) measurement has long been considered the gold standard of vascular assessment for people with lower limb ulceration. Despite this, only around 15% of patients in the United Kingdom who require an ABPI measurement undergo the assessment. The Lanarkshire Oximetry Index (LOI) is a cheaper and arguably more accessible approach to vascular assessment and was initially proposed as an alternative to the ABPI in 2000. No synthesis of evidence related to the LOI has been performed since its introduction into the literature. Primary studies were sought to determine the clinimetric properties of the LOI and its level of agreement with ABPI assessments. Systematic searches of MEDLINE, CINAHL, Cochrane Central Register of Controlled Trials, BNI, ProQuest Health and Medicine, Science Direct, Google Scholar and the British Library (online search) were conducted. Reference lists of identified studies were also reviewed to identify additional studies. Three primary studies met the inclusion criteria, reporting data from 307 patients and 584 limbs assessed using both the LOI and ABPI. All three studies reported fair to moderate kappa values for interrater reliability (κ = 0.290–0.747) and statistically significant positive correlation coefficients (r = 0.37, p < 0.001 in two studies) between the LOI and ABPI. The combined data from the three studies indicated a sensitivity of 52% (41.78–62.1, 95% confidence interval [CI]) and specificity of 96.08% (93.4–97.9, 95% CI) for the LOI using the ABPI as a reference. Additional data are required to indicate the safety of the LOI in practice. Data are also required to determine if the LOI is more acceptable to clinicians compared to the ABPI and whether there are any barriers/enablers to its implementation in practice. Given the relatively low specificity of the LOI, it may be beneficial to combine measurement of the LOI with a subjective clinical risk assessment tool to improve the sensitivity of this alternative approach to vascular assessment.
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