Type 2 diabetic foot ulcer. Type 2 diabetes mellitus with foot ulcer
Conditions
Interventions
Intervention 1: Control group: Wound washing using saline and wound dressing change as standard care. Intervention 2: Intervention group: Wound washing using saline and wound dressing change as standa
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Type II DM according to ADA criteria for less than 20 years Receiving medical care (diet, oral agents, insulin) throughout the disease course Stable hypoglycemic medications (type & dosage) within the last 2 months Existence of at least one foot ulcer with Wound Surface Area = 16 cm2 The ulcer must be classified as grade 2, stage A or C under the UTCS Stable anti inflammatory drugs (drugs prescribed to control HTN or hyperlipidemia) during the last 3 months At least 18 years of age BMI < 35 0.7 = ABI = 1.4 6.5% = HbA1C = 9.5% 100 = FBS = 250 mg/dl Sedentary lifestyle for the last 6 months
Exclusion criteria
Exclusion criteria: Cognitive or mental deficit Wound treatments other than standard care (deemed to be required by the physician) such as growth factors, NPWT, hyperbaric oxygen, special dressings, etc. Ulcer requiring surgical operations other than debridement Non-diabetic ulcers such as electrical, chemical or radiation burns, etc. Pregnancy or breast feeding Infection or OM Critical limb ischemia or lower extremity gangrene Proliferative retinopathy or history of retinal detachment Moderate or severe kidney disease History of major lower extremity amputation Severe liver disease Uncontrolled HTN or BP higher than 160/95 mmHg Life-threatening disease such as malignancy History of DVT during the last 6 months Active cellulitis or collagen vascular disease Active Charcot Present history of smoking or alcoholism Dialysis Immunodeficiency caused by immunosuppressant usage or chemotherapy during the past 2 months, radiotherapy within the last 4 months or systemic diseases Presence of any overt cardiovascular condition diagnosed by cardiologist that prevents the patient from performing vigorous activities Any kind of disease or condition (orthopedic, neurologic, pulmonary, arthritis, etc.) that limits or contraindicates physical activity Presence of any condition considered as absolute contraindication for physical activity by the ACSM’s guideline Participating in any experimental or non-experimental program that requires regular physical activity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound surface area. Timepoint: Baseline, at the end of 4th, 8th and 12th weeks. Method of measurement: Taking pictures and using the "NIH Imagej" software for wound surface area measurement. | — |
Secondary
| Measure | Time frame |
|---|---|
| Quality of life. Timepoint: Baseline and the end of 12th week. Method of measurement: Iranian version of The Short Form 36 Health Survey (SF-36).;Ankle Brachial Index (ABI). Timepoint: Baseline, at the end of 4th, 8th and 12th weeks. Method of measurement: Ankle Brachial Index measurement device which measures systolic blood pressure at arm and ankle levels and calculates the exact value.;5 blood parameters (Interleukin-6, Interleukin-10, Insulin-like Growth Factor-1, Tumor Necrosis Factor-a and Vascular Endothelial Growth Factor). Timepoint: Baseline and at the end of 12th week. Method of measurement: Taking blood samples and using special laboratory kits.;Wound depth. Timepoint: Baseline, at the end of 4th, 8th and 12th weeks. Method of measurement: Using wound depth measurement sterile probe and disposable paper ruler. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Ali Shakoorianfard
Iran University of Medical Sciences
Outcome results
None listed