The effect of combination therapy of vitamin E and C supplements plus Platelet-Rich Plasma-Fibrin Glue on biochemical factors, oxidative stress markers and wound healing rate in diabetic patients

Phase 2

Recruiting

Conditions: Diabetic foot ulcer.
With peripheral circulatory complications
E10-E14

Registration Number: IRCT20190526043711N1

Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

Patients with grade 2- 4 diabetic wounds based on Wagner's classification
Having wounds on the legs and extremities
No smoking, alcohol or drug addiction
Non-use of drugs that may interfere with wound healing, such as corticosteroids, immunosuppressive agents, and cytotoxic agents.
Not having an illness that may cause problems in wound healing, such as cancers, vasculitis
Age between 40 and 75 years
HbA1c over 7 within last 3 months
At least 4 weeks have elapsed since the wounds occurred

Exclusion Criteria

The presence of ulcer with active infection and the need for intravenous antibiotics
Gangrene which needs amputation
Lack of patient referral to the center for tracking and changing dressings in more than two occasions
Previous consumption of vitamin E and C supplements
Patients with renal and hepatic failure and heart failure
Patients with advanced diabetic retinopathy
Pregnancy or breastfeeding
HbA1c more than 11
Occurrence of special medical conditions

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healing rate of the ulcer. Timepoint: At the beginning of the study, and then every week for 2 months. Method of measurement: Examination by a vascular surgery physician and documentation.;The size of the ulcer. Timepoint: At the beginning of the study, and then every week for 2 months. Method of measurement: Measuring by ruler and documentation.

Secondary Outcome Measures