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

Abstract

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. Laboratory examinations and abnormal signs were used to assess the side and toxic effects. 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.

Topical insulin‐liposomal formulation in management of recurrent aphthous ulcers: A randomized placebo‐controlled trial

“…The insulin liposomal formulation was added to chitosan gel that has a wound‐healing activity. Our results were in accordance with several previous reports that have proven the efficacy of topical insulin in accelerating the healing process of skin burns, acute and chronic wounds, and diabetic foot and pressure ulcers…”

“…were 45 (43-47.8) and 48 (41-50) for test and placebo groups, respectively, with a non-significant difference (P = .576). After 6 days, values were 13 (11)(12)(13)(14) and 21 (20)(21)(22)(23)(24)(25)(26)(27)(28) for test and placebo groups, respectively. The test group showed a statistically significantly lower median score than placebo (P < .001) ( Table 2).…”

Acute and Impaired Wound Healing

“…22,23 In animal models of delayed wound healing (diabetic and aged animals), abnormal expression of FGF-1, FGF-2, and FGF-7 and diminished expression of FGFRs have been reported, and exogenous FGFs have been successfully used to improve tissue repair. 24,25 These observations led to development of a number of clinical trials. Fibroblast growth factors 1 and 2 have been used for treatment of chronic wounds and burns, with only modest improvements in healing rates being observed.…”

Regenerative Skin Wound Healing in Mammals: State-of-the-Art on Growth Factor and Stem Cell Based Treatments

“…Administration of FGFs successfully improved wound healing in these animals [85]. In this regard, Tsuboi and Rifkin [86] reported that bFGF (FGF-2) accelerated wound healing in a diabetic mouse model.…”

“…Based on the aforementioned promising animal models, clinical trials in humans were performed where FGF-1 and -2 were used for treating chronic (burn) wounds and resulted in a modest improvement in the healing rates in some studies [81,88]. In another study by Ma et al [89], the use of human recombinant FGF-1 resulted in accelerated healing of deep partial-thickness burn wounds. Future studies may provide better insights on the beneficial effects of different types of FGFs in different patient groups.…”