Short-term effect of dressing with Dermaheal ointment in the treatment of diabetic foot ulcer: A double-blinded randomized controlled clinical trial

Abstract

Background and aims: Diabetic foot ulcers, a major cause of amputations in diabetics, could benefit from natural products as adjuncts to standard care, given the costs and adverse effects of typical therapies. This study aims to evaluate the short-term effects of dressing with Dermaheal ointment in the treatment of DFUs through a double-blinded randomized controlled clinical trial.

Methods: This double-blinded, placebo-controlled trial included 50 patients with Wagner's ulcer grade I or II, randomly assigned to Dermaheal and placebo groups (received standard treatment and placebo ointment). The ulcer site was dressed daily for four consecutive weeks with either Dermaheal or placebo ointment. Ulcer healing score (using DFU healing checklist), ulcer size with transparent ruler and largest dimension of ulcer, and pain severity using numerical pain rating score (were recorded at five-time points, including baseline, and on weeks 1, 2, 3, and 4). Also, ulcer healing status was investigated at the trial ended in November 2021.

Results: Both groups showed significant improvement in ulcer healing over 4 weeks (p _time < 0.001), with more remarkable progress in the Dermaheal group (p _group = 0.03). At the trial end, complete ulcer healing was also significantly higher in the Dermaheal group compared to the placebo group (56% vs. 12%, p = 0.002). Both groups exhibited a decrease in ulcer size (p _time < 0.001). Considering the baseline ulcer size as a covariate, substantial changes in mean ulcer size were noted in the initial (p = 0.01), second (p = 0.001), third (p = 0.002), and fourth (p = 0.002) weeks of the intervention, showing a preference for the Dermaheal group. However, no significant between-group difference was observed in pain severity levels.

Conclusion: Dressing with Dermaheal as a topical treatment shows promise in improving healing and reducing the size of diabetic foot ulcers. Further research is needed to confirm these findings' long-term efficacy.

Keywords: diabetic foot; herbal medicine; skin ulcer; wound healing.

Figure 1

Total diabetic foot ulcer healing score of the study groups at different times.

Figure 2

Diabetic foot ulcer healing status of the study groups at the end of the trial.