High Tone External Muscle Stimulation on Diabetic Foot Ulcer

NCT ID: NCT06664723

Last Updated: 2024-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-03-15

Brief 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.

Detailed Description

1. Assessment measures and procedures:

1- Wound Healing:

1.a- Extent of wound: The wound will be measured using Image J, open source digital imaging software developed at the National Institutes of Health (NIH) to measure wound area of the target wound, in mm2 (the largest foot wound if multiple wounds are present). Image J software has been used specifically for the measurement of diabetic foot ulcers with very high inter- and intra-rater reliability (p=0.997 and 0.999 respectively). The wound will be traced on acetate paper using a fine permanent marker for use in Image J and a standard distance photograph of the wound will be taken to document wound bed characteristics after physician debridement to healthy granulating tissue or healthy bleeding tissue is reached. A completely healed wound has complete epithelialization (William et al., 2017).

1.b-Direct measurement of volume using physiological saline: The wound will be covered with a sterile polyurethane film and then filled up with physiological saline injected using a needle that pierces the film. The quantity of saline corresponds to the wound volume. Wound volume measurements will be taken at baseline, after 4 weeks (midpoint) and after 8 weeks (HUMBERT et al., 2004).

2. Treatment procedures:

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 (Abdel Moez et al., 2022).

Conditions

Diabetic Foot Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

high tone external muscle stimulation

Intervention Type: 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)

Intervention Type: 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.

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.

Group Type: SHAM_COMPARATOR

Standard medical treatment (SMT)

Intervention Type: 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.

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• - Male and female diabetic patients (controlled type II diabetes mellitus) categorized as having a chronic diabetic foot ulcer.
• Patients with unilateral or bilateral grade II (full thickness) diabetic foot ulcers according to Wagner's classification for diabetic foot disease and lasting longer than four months.
• Their ages will range from 45 to 65 years
• All participants will provide informed consent form giving agreement to participation and publication of the results of the study.
• All patients will receive the same medical care for treatment of diabetic foot ulcer and not receiving any physical therapy modalities before the study.

Exclusion Criteria

• - Any pathological conditions or associated injuries affect the result of the study.
• Skin disease or any disease lead to ulcer other than diabetes as venous or arterial disease.
• Active malignancy and osteomyelitis associated with a diabetic foot ulcer.
• Any mental, cognitive and psychological impairment.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Aya Gamal Fawzy El-Sayed

PHD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

Aya Gamal Elsayed, PHD

Role: CONTACT

drayasa3ada@yahoo.com

+0201001475959

Facility Contacts

Physical Therapy Cairo University

Role: primary

Info@pt.cu.edu.eg

0237617691

Other Identifiers

P.T.REC/012/005336

Identifier Type: -

Identifier Source: org_study_id