Diabetic Foot UlcerNCT06664723
High Tone External Muscle Stimulation on Diabetic Foot Ulcer
A study testing high tone external muscle stimulation and Standard medical treatment (SMT) in people with Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- high tone external muscle stimulation and Standard medical treatment (SMT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Nov 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Cairo University
Giza
Physical Therapy Cairo University, 0237617691, Info@pt.cu.edu.eg
About this study
Official title: Effect of High Tone External Muscle Stimulation on Diabetic Foot Ulcer
In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group):
- 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.
- 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.
Read the detailed description
- 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).
- 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
- Being tested
- high tone external muscle stimulation, Standard medical treatment (SMT)
- Keywords
- High tone, Diabetic foot ulcer
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high tone external muscle stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard medical treatment (SMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start15 Nov 2024 (estimated)
- Primary completion15 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Gamal Fawzy El-Sayed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664723
- Sponsor's protocol ID
- P.T.REC/012/005336
- Status last verified
- Oct 2024
- First submitted
- 17 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Tone External Muscle Stimulation on Diabetic Foot Ulcer
- ClinicalTrials.gov ID
- NCT06664723
- Acronym / sponsor ID
- P.T.REC/012/005336
- Conditions
- Diabetic Foot Ulcer
- Keywords
- High tone, Diabetic foot ulcer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 15 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study 80 patients will be randomly assigned into two equal groups (40 patients for each group):
- 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.
- 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
- 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).
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: high tone external muscle stimulation | Experimental | Device: high tone external muscle stimulation, Other: Standard medical treatment (SMT)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 B: Control | Sham comparator | Other: Standard medical treatment (SMT)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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- - 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.
Key exclusion criteria (4 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high tone external muscle stimulationDevice 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 | Device | Group A: high tone external muscle stimulation |
| 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. | Other | Group A: high tone external muscle stimulation, Group B: Control |
Primary outcome
Extent of wound (wound surface area)
Time frame: 8 weeks
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).
Direct measurement of volume (Depth of wound)
Time frame: 8 weeks
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high tone external muscle stimulation and Standard medical treatment (SMT) in people with Diabetic Foot Ulcer, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aya Gamal Elsayed, PHD (+0201001475959, drayasa3ada@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extent of wound (wound surface area) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.