Evaluation of the effect of Pentoxyphilin in treatment of diabetic foot ulcers

Phase 3

Conditions: Diabetic foot ulcer.
Non-insulin-dependent diabetes mellitus With peripheral circulatory complications

Registration Number: IRCT138708041399N1

Lead Sponsor: Semnan university of medical science

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 22

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.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.