A parallel open-label trial to evaluate microbial cellulose wound dressing in the treatment of diabetic foot ulcers.

The purpose of this study was to compare the rate of wound healing in diabetic foot ulcers (DFU) using either a microbial cellulose (MC) wound dressing or Xeroform™ Petrolatum gauze. In a parallel, open-label trial in which the primary outcome was the rate of wound healing and the time to wound closure, 15 ulcers in type II diabetic patients received an MC dressing. Wounds in 19 control patients with type II diabetes were treated with a Xeroform gauze dressing. All wounds were non infected, Wagner stage II or III and received standard care including debridement, non weight bearing limb support and weekly wound evaluation. The mean time to heal in the MC (±SE) treated group was 32 days ± 2.5 and for controls it was 48 days ± 4.7 (P < 0.01). The rate of weekly wound closure (mean ± SE) was 1.7 times faster in the MC-treated group (cellulose treated, -5.04% per week ± 0.38 versus control, -2.93% per week ± 0.19), (P < 0.001). Among covariants tested by univariate regression, only the original wound area correlated with the time to wound closure (P < 0.001). In conclusion, with the provision of current standards of care, the application of an MC dressing to a diabetic ulcer may enhance the rate of wound healing and shorten the time course of epithelisation.

RCT Entities:   Population Interventions Outcomes