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Chronic diabetic foot ulcers (DFUs) complicated by osteomyelitis remain a major clinical challenge, often requiring aggressive treatments or surgical intervention. Novel non-invasive approaches such as laser and plasma therapy have shown promise in enhancing wound healing and reducing infection. As part of a broader study involving 20 patients with chronic DFUs (14 females and 6 males), a dual-modality treatment combining low-level laser therapy and PRP therapy was applied. Among the participants, two representative cases are presented in detail to highlight the clinical outcomes and treatment potential of this method. The first case involves a 65-year-old male with a chronic heel ulcer unresponsive to conventional therapies. The second case is a 58-year-old female with a necrotic toe and persistent ulceration. Treatment consisted of multiple sessions of laser and plasma therapy, integrated with standard wound care protocols. Progress was monitored through wound size, tissue regeneration, infection control, and overall healing response. Both patients demonstrated substantial clinical improvement, including resolution of necrotic tissue, reduction in wound size, and formation of healthy granulation tissue. No adverse effects were observed, and neither patient required surgical amputation. Further controlled studies are recommended to validate and generalise these findings.
Irritant contact dermatitis is a common peristomal skin complication. Due to the continuous irritation from intestinal fluids and faeces, the healing of this dermatitis is slow and the condition severely impairs patients' quality of life. The study aimed to evaluate the efficacy of a modified insertable ostomy appliance in promoting healing and improving patient outcomes. A randomised controlled trial was conducted from January 2022 to December 2024 in a tertiary hospital. The enrolled patients, all diagnosed with irritant contact dermatitis, were randomly assigned to two groups. The control group wore the conventional two-piece ostomy appliance, while the experimental group wore the modified insertable ostomy appliance. Outcomes were assessed on Days 3, 7, 14 and 28. The primary outcome was the healing rate (Discoloration, Erosion and Tissue overgrowth [DET] score ≤ 2) at Day 28. Secondary outcomes included the DET score, Visual Analogue Scale (VAS) pain score, Stoma Quality of Life questionnaire (Stoma-QOL) score and the incidence of appliance leakage. A total of 89 eligible participants completed the trial. The experimental group showed a significantly higher 28-day healing rate (73.3% vs. 29.5%, p < 0.001), lower DET scores (Day 28: 2.0 vs. 4.5, p < 0.001), reduced VAS scores (Day 28: 1.5 vs. 2.0, p < 0.001), higher Stoma-QOL scores (Day 28: 55.67 vs. 51.64, p < 0.001) and lower leakage rate (13.3% vs. 93.2%, p < 0.001). The modified ostomy appliance significantly improves healing, reduces pain and enhances quality of life, representing a novel solution for clinical practice.
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
A novel advanced synthetic bioactive glass matrix was studied in patients with non-healing diabetic foot ulcers (DFUs). Bioactive glasses can be constructed to be biocompatible, with water-soluble materials in multiple geometries including fibre scaffolds that mimic the 3D architecture of a fibrin clot. In this trial, chronic, Wagner Grade 1 DFUs were randomised to receive borate-based bioactive glass Fibre Matrix (BBGFM) plus standard of care (SOC) therapy for 12 weeks or SOC alone. The primary study endpoint was the proportion of subjects that obtained complete wound closure at 12 weeks. Secondary endpoints included time to achieve complete wound closure at 12 weeks. In the modified intent-to-treat (mITT) analysis, 48% (32/67) treated with BBGFM plus SOC healed at 12 weeks compared to 24% (16/66) with SOC alone (p = 0.007). In the per protocol (PP) population, 73% (32/44) of subjects treated with BBGFM plus SOC healed versus 42% (16/38) in the SOC group (p = 0.007). Based on the success of this trial, BBGFM demonstrates faster healing of DFUs compared to SOC and should be considered in the treatment armamentarium for Wagner Grade 1 DFUs. Future trials should investigate the use of BBGFM for healing deeper chronic DFUs, other wound aetiologies, or complex surgical wounds.
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