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

Investigating the effect of oxygen therapy dressing for the treatment of diabetic foot ulcers containing granulation tissue

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240502061627N1
Enrollment
20
Registered
2024-05-18
Start date
2024-05-14
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healing wound. Type 1 diabetes mellitus with circulatory complications

Interventions

Intervention group: intervention group: using a novel oxygen-based wound dressing technique in diabetic patients with foot ulcers featuring granulation tissue. The intervention involves a thorough ass

Sponsors

Babol University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 64 Years

Inclusion criteria

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

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%

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahmod Sadeghi hadad zavareh

Babol University of Medical Sciences

drm_sadeghihz@yahoo.com+98 11 3231 2345

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026