Evaluation of the effect of the herbal medicine Wound Healer on the healing of diabetic foot ulcers: A randomized double-blind clinical trial

The effect of Wound Healer on the treatment of neuropathic and neuro-ischemic diabetic wounds in patients with diabetic foot

The diabetic patients included in the study (n = 80) will be studied as Block Randomization. These groups will be matched for the nature of the wounds, the entry and exit factors, and other influencing factors. Patients will be evaluated weekly by the clinic for discharge, color, and size of the wound, and the results will be recorded in the relevant table. The first and last visit will be done by an endocrinologist or infectious disease specialist and the second, third and fourth visits by the trained person. Medicines will be delivered to patients each week and a blank package will be delivered the following week.

Diabetes Clinic of Diabetes Research Center

Inclusion criteria are: 1. Neuropathic, neuro-ischemic diabetic foot ulcer 2. Have signed informed consent to participate in the study 3. No skin diseases in the foot area 4- Diabetic foot ulcers with grade I, II and III lesions according to Wagner's diagnostic criteria 5. Age less than 70 years. Exclusion criteria are: 1. Pregnancy and lactation 2- Having autoimmune diseases and cancer Brachial leg index lower than 0.7 4- People with HbA1c greater than 8 to 9% (people with uncontrolled blood sugar)

In this study, we aimed to investigate the therapeutic effect of Wound Healer on healing of infectious diabetic foot ulcers. We need two groups for this purpose: 1. People with infectious wounds who receive their usual antibiotic treatment. 2. People with infectious wounds who receive topical Wound Healer in addition to antibiotic treatment for 4 weeks daily.

1- Shortening the time of wound healing or closing 2-Symptoms of a wound infection can be resolved 3-Reduce the size of the wound by 50%

The sample randomization method will be based on the Block Randomization table. Patients with diabetic foot ulcer are divided into two groups of "control and medication" based on the block randomization table after examination and if they meet the inclusion criteria. The doctor and nurse will not play a role in determining the treatment group.

Regarding of how the patients are randomly selected and the principal that investigator is separated from the treatment team, physicians and nurse practitioners will not play a role in selecting patients for treatment groups, and patients will be unaware of their treatment grouping.