Wound repair and regeneration : official publication of the Wound Healing Society [and] the European Tissue Repair Society
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Randomized Controlled Trial
NorLeu3-A(1-7) stimulation of diabetic foot ulcer healing: results of a randomized, parallel-group, double-blind, placebo-controlled phase 2 clinical trial.
This randomized, double-blind, placebo-controlled Phase 2 clinical trial explored NorLeu(3)-A(1-7) (DSC127) safety and healing efficacy in diabetic foot ulcers. Patients with chronic, noninfected, neuropathic, or neuroischemic plantar Wagner Grade 1 or 2 foot ulcers (n = 172) were screened for nonhealing. Subjects were randomized to receive 4 weeks' once-daily topical treatment with 0.03% DSC127 (n = 26), 0.01% DSC127 (n = 27), or Placebo (n = 24), followed by 20 weeks' standard of care. ⋯ Covariate analysis compared reduction in ulcer area, depth, and volume from baseline; reductions in the 0.03% DSC127 group were greater at Weeks 12 and 24. Placebo-treated ulcers healed in a median 22 weeks vs. 8.5 weeks for 0.03%DSC127 (p = 0.04). This study provides preliminary evidence that DSC127 is safe and effective in accelerating the healing of diabetic foot ulcers.
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Randomized Controlled Trial Multicenter Study
A multicenter clinical trial of recombinant human GM-CSF hydrogel for the treatment of deep second-degree burns.
Wound healing is a complex and dynamic biological process. The efficacy and safety of a recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) hydrogel to promote deep-second-degree burn wound healing is evaluated in this study. In this multicenter, randomized, double-blind, and placebo-controlled clinical trial, 90 patients with deep second-degree burns were randomly assigned into two groups. ⋯ A statistically significant difference was noted at each time point (p<0.01). No side effects were observed. These results suggest that rhGM-CSF hydrogel can significantly accelerate deep second-degree burn wound healing and is considered to be safe.
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Randomized Controlled Trial Multicenter Study Comparative Study
Reducing wound pain in venous leg ulcers with Biatain Ibu: a randomized, controlled double-blind clinical investigation on the performance and safety.
Six out of 10 patients with chronic wounds suffer from persistent wound pain. A multinational and multicenter randomized double-blind clinical investigation of 122 patients compared two moist wound healing dressings: a nonadhesive foam dressing with ibuprofen (62 patients randomized to Biatain Ibu Nonadhesive Coloplast A/S) and a nonadhesive foam without ibuprofen (60 patients to Biatain Non-Adhesive-comparator). Patients were recruited from September 2005 to April 2006. ⋯ It was generally found that women reported less pain intensity than men, and pain intensity decreased with increasing age. In addition, pain intensity increased with initial pain intensity and increasing wound size. This study has demonstrated that the ibuprofen-foam dressing provided pain relief and reduced pain intensity without compromising healing or other safety parameters.
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Randomized Controlled Trial Multicenter Study
Randomized, multicenter, double-blind, and placebo-controlled trial using topical recombinant human acidic fibroblast growth factor for deep partial-thickness burns and skin graft donor site.
Wound healing is a dynamic and complex biologic process that could be accelerated by growth factors. To investigate the efficacy of topical recombinant human acidic fibroblast growth factor (rh-aFGF) treatment in deep partial-thickness burn or skin graft donor sites, we designed a randomized, multicenter, double-blind, and placebo-controlled clinical trial. The healing rate, fully healed rate, and healing time were evaluated to assess the efficacy of rh-aFGF application. ⋯ The results showed that the healing rate of burn wounds and skin graft donor sites treated by rh-aFGF was significantly higher than that by placebo, and the mean healed time of burn wounds and skin graft donor sites in the rh-aFGF group was significantly the shorter than that in the placebo group. In conclusion, topical administration of rh-aFGF can accelerate the wound healing process and shorten the healed time. It is a potential therapeutic application for promoting healing of deep partial-thickness burns or skin graft donor sites.
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Randomized Controlled Trial Clinical Trial
Growth hormone effects on hypertrophic scar formation: a randomized controlled trial of 62 burned children.
The hypercatabolism after massive pediatric burns has been effectively treated with recombinant human growth hormone, an anabolic agent that stimulates protein synthesis and abrogates growth arrest. While experimental studies have shown increased potential for fibrosis induced by growth hormone therapy, adverse effects on human scars have not been investigated. Our aim was to evaluate hypertrophic scar formation in 62 patients randomized to receive injections of 0.05 mg/kg/day of recombinant human growth hormone or placebo, from discharge until 1 year after burn. ⋯ Insulin-like growth factor-1 was significantly increased in the recombinant human growth factor-treated group. No differences were seen when recombinant human growth factor and control groups were compared using the scar scales, planimetry, or immunohistochemistry. We concluded that recombinant human growth hormone therapy did not adversely affect scar formation and should not contraindicate the administration of recombinant human growth hormone as a therapeutic approach to severely burned children.