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High Tone External Muscle Stimulation on Diabetic Foot Ulcer
Sponsor: Cairo University
Summary
In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group): 1. Group A: Experimental: (high tone external muscle stimulation for diabetic foot ulcer). The study group will include 40 patients with diabetic foot ulcer receiving high tone external muscle stimulation three times a week for 8 weeks; in addition to Standard Medical Treatment: The Standard care of diabetic foot ulcers includes good glycemic control, adequate nutrition, off-loading (via bed rest or casts), local care (moist dressings and topical management), lessening of edema, surgical debridement of devitalized wound tissue and antibiotic therapy. 2. Group B: Control: The control group will include 40 patients with diabetic foot ulcer receiving Standard Medical Treatment only. The Standard care of diabetic foot ulcers includes good glycemic control, adequate nutrition, off-loading (via bed rest or casts), local care (moist dressings and topical management), lessening of edema, surgical debridement of devitalized wound tissue and antibiotic therapy.
Official title: Effect of High Tone External Muscle Stimulation on Diabetic Foot Ulcer
Key Details
Gender
All
Age Range
45 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2024-11-15
Completion Date
2025-03-15
Last Updated
2024-10-29
Healthy Volunteers
No
Conditions
Interventions
high tone external muscle stimulation
Device HiToP®: Parameters of (HTEMS), Voltage: 230-V Pulse widths: ≤350 mA. Electrical Frequency: Frequencies continuously scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 m W. Intensity: the electrical stimulation will be adjusted to a pleasant level that will not produce any pain or discomfortable paraesthesia, Duration 30 minutes per session. Electrodes will be placed around ulcer. It will be introduced 3 times per week, for 8 weeks Prior to intervention, skin sensation will be assessed using warm water in a test-tube (temperature), pin prick (pain) and cotton wool (light touch) to ascertain the skin sensitivity
Standard medical treatment (SMT)
The Standard care of diabetic foot ulcers includes good glycemic control, adequate nutrition, off-loading (via bed rest or casts), local care (moist dressings and topical management), lessening of edema, surgical debridement of devitalized wound tissue and antibiotic therapy.
Locations (1)
Cairo University
Giza, Egypt