Abstract:

Objective

To observe the effect and safety of ulcer oil in the treatment of diabetic foot ulcer.

Methods

A total of 100 patients with diabetic foot who were admitted to the Department of Surgery of Traditional Chinese Medicine， China-Japan Friendship Hospital from September 2020 to September 2023 were enrolled and divided into observation group and control group randomly according to the random number table method， with 50 patients in each group.Both groups received standard treatment for diabetes mellitus，and the foot wounds were cleaned and treated with weekly dressing changes， which were performed two to three times.The observation group applied a topical ulcer oil in addition to the conventional treatment， while the control group applied a topical recombinant human epidermal growth factor in addition to the conventional treatment.The course of treatment for both groups was 12 weeks.At the 6th and 12th weeks of treatment， a comparison was made between the two groups in respect of the wound area， wound healing rate and proportion of patients with wound healing， traditional Chinese medicine syndrome score of the patients were calculated.Prior to and at the conclusion of the treatment period，the blood routine，liver and kidney function indexes of the two groups were evaluated.It was also necessary to observe whether any adverse events， such as an exacerbation of infection or an allergic reaction，occurred during the course of treatment in either group.

Results

Following the 6th and 12th weeks of treatment，no statistically significant differences were observed between the two groups in terms of wound area， wound healing rate， proportion of patients with wound healing， and total effective rate， as assessed by the efficacy of traditional Chinese medicine evidence （P＞0.05）.The observed differences in the levels of white blood cell count， red blood cell count， haemoglobin，platelet count， alanine transaminase， aspartate aminotransferase， total bilirubin， urea， blood glucose， and creatinine in the observation group were not statistically significant when compared with the levels recorded prior to the commencement of treatment （P＞0.05）.Following treatment， the red blood cell count and haemoglobin level of the observation group were found to be higher than those of the control group［（4.20±0.91）×10¹²/L vs （3.48±0.68）×10¹²/L，（123.07±19.29）g/L vs （102.56±19.68）g/L］，the differences were statistically significant （t=5.873，5.724； P＜0.001）.No adverse events were observed in either group during the course of treatment.

Conclusion

Ulcer oil can effectively promote the healing of diabetic foot ulcers and reduce the clinical symptoms of the patients，and has a better safety profile.

Key words: Diabetic foot, Ulcer, Safety, Clinical efficacy