egative pressure versus standard wound therapy for diabetic foot
Phase 2
- Conditions
- Diabetic foot ulcers.Personal history of diabetic foot ulcerZ86.31
- Registration Number
- IRCT20231201060234N2
- Lead Sponsor
- CMH Peshawar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
Included all patients >18 years diagnosed clinically and BSF and 2-hour-post prandial investigations in the diabetic range according to the WHO criteria
Presenting with a diabetic foot wound of more than 4 weeks duration corresponding to Wagner grade 2 for debridement.
Exclusion Criteria
Included patients < 18 years
Pregnancy
Non-compliant to follow-up
Necrotic tissue on ulcer with eschar that could not be debrided
Malignancy, advanced cardiac and respiratory disease
Exposed nerve and vessels beneath the ulcer and patient with above ankle ulcer and those with Charcot arthropathy.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean wound closure time. Timepoint: During or after 12 weeks of therapy. Method of measurement: Subjective assessment by 3 consultants.
- Secondary Outcome Measures
Name Time Method Median pain scores. Timepoint: After 12 weeks of therapy. Method of measurement: Standard Visual Analog Scale for pain and Likert scale for satisfaction.;Incidence of infection. Timepoint: During 12 weeks of therapy. Method of measurement: Subjective by 3 independent consultants.