High Tone External Muscle Stimulation on Diabetic Foot Ulcer

Sponsor
Cairo University
Study ID
NCT06664723
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • high tone external muscle stimulation — DEVICE
    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) — OTHER
    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.

Study Details

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.

Key Dates

First listed
Oct 29, 2024
Start date
Nov 15, 2024
Status verified
Oct 2024
Primary completion
Jan 15, 2025
Completion
Mar 15, 2025

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group A: high tone external muscle stimulation
    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.
  • Sham Comparator: 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.

Primary Outcome Measure

Extent of wound (wound surface area) [ Time Frame: 8 weeks ]

Central Contacts

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