yophilized human amniotic membrane; a dressing for chronic diabetic foot wound healing
Phase 2
Recruiting
- Conditions
- Diabetic foot ulcer.E11
- Registration Number
- IRCT20190131042570N1
- Lead Sponsor
- Stem Cell and Regenerative Medicine Research Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
patient with chronic diabetic foot
HbA1C<8
ulcer duration less than one year
having dorsalis pedis and posterior tibialis pulses
Ulcer size =1 cm2 and < 25 cm2
No clinical signs of infection
Exclusion Criteria
other therapies in the last three months
immunocompromised patient
patients with history of allergy or hemostasis disorders
Pregnant or breast feeding
received corticosteroids or immunosuppresive drugs in the last six months
smoking cigarette
Known or suspected malignancy of current ulcer
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method lcer size. Timepoint: at baseline, in 1 week, 2 weeks, 4 weeks and 6 weeks. Method of measurement: by ruler.
- Secondary Outcome Measures
Name Time Method