High Tone External Muscle Stimulation on Diabetic Foot Ulcer

NCT06664723 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/005336
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group):

1. 1.Group A: Experimental: (high tone external muscle stimulation for diabetic foot ulcer).
2. 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.

Conditions

Diabetic Foot Ulcer

Keywords

High tone; Diabetic foot ulcer

Outcome Measures

Primary Outcomes (2)

• Extent of wound (wound surface area)

  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).

  8 weeks

• Direct measurement of volume (Depth of wound)

  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).

  8 weeks

Study Arms (2)

Group A: high tone external muscle stimulation

EXPERIMENTAL

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.

Device: high tone external muscle stimulation; Other: Standard medical treatment (SMT)

Group B: Control

SHAM COMPARATOR

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.

Other: Standard medical treatment (SMT)

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

Group A: high tone external muscle stimulation

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.

Group A: high tone external muscle stimulation; Group B: Control

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Central Study Contacts

Aya Gamal Elsayed, PHD

CONTACT

+0201001475959; drayasa3ada@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PHD

Study Record Dates

• First Submitted: October 17, 2024
• First Posted: October 29, 2024
• Study Start: November 15, 2024
• Primary Completion: January 15, 2025
• Study Completion: March 15, 2025
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

EG (1)