Efficacy of platelet gel on diabetic foot ulcer
Phase 3
- Conditions
- Condition 1: Insulin-dependent diabetes mellitus. Condition 2: Non-insulin-dependent diabetes mellitus. Condition 3: Other specified diabetes mellitus. Condition 4: Unspecified diabetes mellitus.Insulin-dependent diabetes mellitusNon-insulin-dependent diabetes mellitusOther specified diabetes mellitusUnspecified diabetes mellitus
- Registration Number
- IRCT2015123018842N10
- Lead Sponsor
- Hematology, Oncology and Stem Cell Transplantation Reseach Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
Patients with chronic DFUs were enrolled in the study. Chronic DFU, considered as a wound in an extremity (mostly foot) of a known diabetic patient which has not decreased by 50% of the primary size in one month (Inclusion criteria). No other limitations such as age, sex, fasting blood sugar (FBS) or hemoglobin A1C (Hb A1C) levels were applied.Exclusion criteria included osteomyelitis, malignant arterial insufficiency, exposed bone in an ulcer, antibiotic resistance DFU, wounds with Charcot deformity, history of anti-proliferative medication or radiation in past 3 months, serum Hb<10 mg/dL, platelet count<103/µL and history of growth factor therapy within last 2 weeks.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method lcer size. Timepoint: weekly up to full healing. Method of measurement: Ruler.
- Secondary Outcome Measures
Name Time Method Efficacy of platelet gel on prevention of foot amputation. Timepoint: mounthly after strat treatment. Method of measurement: visit by surgeon.