The Effect of 12-week Aerobic and Lower Extremity Resistance Exercises on Healing of Foot Ulcers in Type 2 Diabetic Patients

Not Applicable

• Conditions: Type 2 diabetic foot ulcer.; Type 2 diabetes mellitus with foot ulcer; E11.621

• Registration Number: IRCT20201214049723N1
• Lead Sponsor: Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 June 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 26

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.