High Tone External Muscle Stimulation on Diabetic Foot Ulcer

NANot yet recruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 15, 2024

Primary Completion Date

January 15, 2025

Study Completion Date

March 15, 2025

Conditions
Diabetic Foot Ulcer
Interventions
DEVICE

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

OTHER

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.

Trial Locations (1)

Unknown

Cairo University, Giza

All Listed Sponsors
lead

Cairo University

OTHER

NCT06664723 - High Tone External Muscle Stimulation on Diabetic Foot Ulcer | Biotech Hunter | Biotech Hunter