Diabetic foot ulcer. Diabetes mellitus due to underlying condition
Conditions
Interventions
Intervention 1: Intervention group: injection of 1ml dextrose 10% per each cm2 of wound up to 10ml, 3 times per week, in the base and periphery of wound. Intervention 2: Control group: injection of 1m
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age > 18 years old Patients with confirmed type 1 or 2 diabetes mellitus HbA1C = 7-10% Ability to understand and collaborate during the study Having at least one chronic ulcer lasting for more than 4 weeks Plantar or dorsal or malleolar ulceration ABI = 0.7 - 1.2 in ischemic ulcers Ulcers with Wagner grades 2, 3 Ulcers with wound area = 1-20 cm2 None of the patients had received glucocorticoid, estrogen, or other drugs that interfere healing process within the past 1 month Patients who signed the informed consent
Exclusion criteria
Exclusion criteria: Patients with a history of malignancy or coagulopathy GFR < 30 ml/min/1.73m2 Albumin level < 3.5 g/dl Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound area. Timepoint: Before intervention and 7, 14, 21 and 28 days after intervention. Method of measurement: Digital imaging to measure wound area.;Patient's pain scale. Timepoint: Before intervention and 7, 14, 21 and 28 days after intervention. Method of measurement: Visual Analogue Scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| White blood cell. Timepoint: Before and after intervention. Method of measurement: Complete blood cells test.;Erythrocyte sedimentation rate. Timepoint: Before and after intervention. Method of measurement: Quantitative measurement of erythrocyte sedimentation rate in blood.;C-reactive protein. Timepoint: Before and after intervention. Method of measurement: Quantitative measurement of C-reactive protein in blood.;Blood glucose. Timepoint: Before and after intervention. Method of measurement: Glucometry.;Ankle - Brachial index. Timepoint: Before and after intervention. Method of measurement: Doppler sonography. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAsma Mafhoumi
Tehran University of Medical Sciences
Outcome results
None listed