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Short-term effect of dressing with Dermaheal ointment in the treatment of diabetic foot ulcer: A double-blinded randomized controlled clinical trial.
Salahi, Pouya; Nasiri, Morteza; Yazdanpanah, Leila; Khosravi, Sepehr; Amini, Mohammad Reza.
Afiliação
  • Salahi P; Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute Tehran University of Medical Sciences Tehran Iran.
  • Nasiri M; Department of Operating Room Nursing, School of Allied Medical Sciences Tehran University of Medical Sciences Tehran Iran.
  • Yazdanpanah L; Health Research Institute, Diabetes Research Center Ahvaz Jundishapur University of Medical Sciences Ahvaz Iran.
  • Khosravi S; Non-Communicable Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute Tehran University of Medical Sciences Tehran Iran.
  • Amini MR; Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute Tehran University of Medical Sciences Tehran Iran.
Health Sci Rep ; 7(2): e1868, 2024 Feb.
Article em En | MEDLINE | ID: mdl-38357487
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.
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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Health Sci Rep Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Clinical_trials Idioma: En Revista: Health Sci Rep Ano de publicação: 2024 Tipo de documento: Article