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Clinical Trials/IRCT20240502061627N1
IRCT20240502061627N1
Recruiting
Phase 1

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

Babol University of Medical Sciences0 sites20 target enrollmentTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
healing wound.
Sponsor
Babol University of Medical Sciences
Enrollment
20
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • 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%

Outcomes

Primary Outcomes

Not specified

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