Diabetic foot ulcer. Non-insulin-dependent diabetes mellitus With peripheral circulatory complications
Conditions
Interventions
Intervention 1: Pentoxyphiline (Oral capsule, 400 mg, BID for 3 months). Intervention 2: Flour filled capsules as placebo(Oral capsule like Penthoxyphilin, BID for 3 months).
Treatment - Drugs
Pentoxyphiline (Oral capsule, 400 mg, BID for 3 months)
Flour filled capsules as placebo(Oral capsule like Penthoxyphilin, BID for 3 months)
Sponsors
Semnan university of medical science
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Presence of NIDDM (Non insulin dependent diabetes mellitus), presence of foot ulcer, HbA1C one unit more than normal range. Exclusion Criteria: Serum Alb<3.5 mg/dL, presence of peripheral vascular disease, non-palpable Dorsalis pedis & Tibialis posterior pulses, consumption of Glucocorticoids and Warfarin, contraindication for Pentoxyphilin.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing of diabetic foot ulcer. Timepoint: Baseline, every one month for 3 months. Method of measurement: Decrease of the wound size relative to original size: length in Linear wounds (mm), surface in planar wounds (mm^2), volume in 3 dimensional wounds (mm^3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Drug adverse effects. Timepoint: 3 months. Method of measurement: Clinical manifestations of Dizziness or Retinal hemorrhage.;Need to debridement. Timepoint: 3 Months. Method of measurement: proportion of patients who need debridment.;Need to amputation. Timepoint: 3 months. Method of measurement: proportion of patients who need amputation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Setareh Soltany
Semnan University of Medical Sciences
Outcome results
None listed