Effect of a topical gel containing Sumac extract and Cloxacillin on diabetic foot ulcer

Phase 2

Recruiting

Conditions: Condition 1: Diabetic foot ulcer caused by type 1 diabetes. Condition 2: Diabetic foot ulcer caused by type 2 diabetes.
Type 1 diabetes mellitus with diabetic peripheral angiopathy without gangrene
Type 2 diabetes mellitus with diabetic peripheral angiopathy without gangrene
E10.51
E11.51

Registration Number: IRCT20220310054247N1

Lead Sponsor: Karaj University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 66

Inclusion Criteria

Patients with type 1 or 2 Diabetes
Age 30 years or older
Grade 1 and 2 diabetic ulcers according to Wagner classification system
Adherence to routine diabetes treatments
Ankle Brachial Index (ABI) greater than 0.7

Exclusion Criteria

Pregnancy or Breastfeeding
Presence of infection in the wound before admission
Presence of neoplasia
Use of immunosuppressive drugs

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Wound area and dimensions. Timepoint: Weekly for 8 weeks. Method of measurement: Photography of ulcers and Computer software.;Presence or absence of infection in the wound. Timepoint: Weekly for 8 weeks. Method of measurement: Wound examination and Visual observation.

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects. Timepoint: Evaluation will be weekly from the first week to the eighth week. Method of measurement: Asking the patient and Examining the wound by the visitor (symptoms such as burning, itching, redness, etc. while using the gel).;Tolerability. Timepoint: Evaluation will be weekly from the first week to the eighth week. Method of measurement: Ask the patient if there is any discomfort while taking the drug or If there is any factor that makes the patient reluctant to continue treatment and the cause is related to the gel used.;Pain assessment. Timepoint: Before the intervention and the end of the eighth week. Method of measurement: The patient scores from one to ten, depending on the amount of pain he feels.(Visual Analogue Scale).;Quality of life score. Timepoint: Before the intervention and the end of the eighth week. Method of measurement: Questionnaire for quality of life of patients with diabetic foot ulcers.(Designed by Johnson in the UK, 1995).