Investigating the effect of a new oxygen-based wound treatment dressing in the healing of diabetic foot ulcers containing granulation tissue

Phase 1

Recruiting

• Conditions: healing wound.; Type 1 diabetes mellitus with circulatory complications; E10.5

• Registration Number: IRCT20240502061627N1
• Lead Sponsor: Babol University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Middle-aged men and women (40 to 64 years old)
• Suffering from a diabetic foot ulcer for at least 4 weeks, or suffering from an amputation wound
The initial area of the wound should be measured at least 0.5 and at most 25 square centimeters in the first visit
Having a wound with Wegener grade 1 and 2 (Wegener grade is explained below)
• Sufficient blood supply to the involved organ during the three months before the start of the study, which is determined by the ankle brachial index of 0.7 to 1.3
The studied wound has no necrotic tissue and needs debridement for at least 14 days before

Exclusion Criteria

Suffering from an uncontrolled major disease such as serious cardiovascular disease, kidney, liver, lung, lupus, anemia, tuberculosis and patients undergoing palliative treatment.
Patients with an active malignancy, or a history of malignancy in the wound
Sensitivity to treatment components
Patients with a history of taking immunosuppressive drugs for more than 2 weeks, such as corticosteroids more than 10 mg daily and cytotoxic chemotherapy drugs, or placing topical steroids on the wound for at least one month before entering the study, or during the study. or predicting the need for such treatment in the course of the study
HbA1C >12%

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete healing of diabetic wounds. Timepoint: every 48 hours for 12 weeks. Method of measurement: Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.;Percentage reduction of diabetic ulcers. Timepoint: every 48 hours for 12 weeks. Method of measurement: Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.;Incidence of dressing Complications. Timepoint: every 48 hours for 12 weeks. Method of measurement: Patients' wounds are photographed during each follow-up stage, and these images undergo two-dimensional and three-dimensional assessment using the newest Tissue Analytics software for Android.