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IRCT20201214049723N1 IRCT 2021-01-07 Iran University of Medical Sciences The Effect of 12-week Aerobic and Lower Extremity Resistance Exercises on Healing of Foot Ulcers in Type 2 Diabetic Patients The Effect of 12-week Aerobic and Lower Extremity Resistance Exercises on Healing of Foot Ulcers in Type 2 Diabetic Patients 2021-06-22 anticipated 26 Complete https://irct.ir/trial/53080 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified block randomization using "dressing type" as matching factor between the groups. Online Randomization software will be used in randomization process. There will be 6 blocks, each containing 4 letters (e.g. AABB) as half of each block belongs to the control group and the other half belongs to the interventional group. These 6 blocks will be sorted out in a randomized fashion as well. The blocks will be placed in different sealed envelopes prepared by a third party that has no participation in any of the research stages whatsoever. Each time one of these envelopes will be unsealed randomly and 4 patients will be allocated according to the sequence of the letters inside that block. Then the envelope will be sealed and put in its position again, Blinding description: Outcome assessor will be blind to allocation before and after the intervention period. N/A Type 2 diabetic foot ulcer. 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 standard care + 12 weeks (3 sessions/week) of supervised aerobic and resistance exercise and home based range of motion exercise (3 days/week). No - There is not a plan to make this available Justification or reason for not sharing IPD is Iran University of Medical Sciences will decide whether to publish the data or not.
public Mohammad Ali Shakoorianfard
No. 41, 5th alley, Najafzadeh Ave., Basij Blvd.
Qom Iran (Islamic Republic of) 3715966345 +98 25 3783 1505 mashakoorianfard1995@gmail.com Iran University of Medical Sciences scientific Dr. Behnoosh Vasaghi
Department of Basic Sciences in Rehabilitation, School of Rehabilitation Sciences, Madadkaran alley, Shahnazari Ave., Madar Sq., Mirdamad St.
Tehran Iran (Islamic Republic of) 1545913487 +98 21 2222 7124 bvasaghi@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) 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 18 years no limit Both 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 E11.621 Type 2 diabetes mellitus with foot ulcer Treatment - Other Treatment - Other Control group: Wound washing using saline and wound dressing change as standard care Intervention group: Wound washing using saline and wound dressing change as standard care + 12 weeks (3 sessions/week) of supervised aerobic and resistance exercise and home based range of motion exercise (3 days/week) 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. 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-α 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. Iran University of Medical Sciences Approved 2020-12-06 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemmat Hwy. Tehran Tehran Iran (Islamic Republic of)