Diabetic Foot UlcerNCT07109895
Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers
A study of Diabetic Foot Ulcer, run by University of Lahore at 1 site in Pakistan.
Trial summary
Diabetic foot ulcers (DFUs) are one of the serious complications of diabetes, typically resulting from neuropathy or peripheral arterial disease, and can often lead to amputation. It affects approximately 6.3% of people with diabetes globally. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Aug 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old with type 1 and 2 diabetes
- Both Males and Females
- Having Foot ulcers in Grade 1 and Grade 2 according to the Wagner Classification
Who cannot join
- History of amputation (proximal to the trans-metatarsal joint)
- Active or inactive Charcot foot
- Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS)
- Leg length discrepancy
- The presence of any allergic condition of the skin,
- Chronic consumption of opioids,
Show all 10Show fewer
- Use of a cardiac pacemaker,
- Major bone operation,
- Neurological illness, such as a vestibular disorder with a history of dizziness 10. Mental disorders, which might interfere with the assessment process
- 11. Dementia or impaired cognitive function
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
University of Lahore
Lahore, Punjab Province, 54000
Ayesha Jamil, M.Phil Physiotherapy, +92 324 4481031, ayeshabutt031@gmail.com
Maryam Shabbir, PhD Rehabilitation, maryam.shabbir@uipt.uol.edu
About this study
Official title: Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers
Diabetic foot ulcers (DFUs) are one of the serious complications of diabetes, typically resulting from neuropathy or peripheral arterial disease, and can often lead to amputation. It affects approximately 6.3% of people with diabetes globally. In Pakistan, the overall prevalence of DFUs is 16.83%, with a slightly higher rate in females. Diabetic foot ulcers are the main reason for lower extremity amputation (LEA) with non-traumatic origin, hospitalization, healthcare costs, and mortality.
Read the detailed description
Diabetic foot ulcers (DFUs) are a significant complication of diabetes, carry a high risk of amputation and disability, and affect around 6.3% of diabetic patients globally. Risk factors for DFUs include pre-ulcerative lesions, mechanical pressure, restricted mobility, and poor glycemic control. Peripheral neuropathy plays a crucial role in DFU development, causing structural and functional changes in the foot.
Offloading interventions, such as prefabricated orthotics and custom insoles, are essential for preventing DFU development and promoting ulcer healing. Physiotherapy modalities like therapeutic exercise and electrotherapy can assist in tissue repair and pain management. Orthotic management complements rehabilitation efforts, potentially reducing the risk of wound development. Further research on the combined benefits of transcutaneous electrical nerve stimulation (TENS) and customized insoles for DFUs is necessary to enhance clinical outcomes.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Standard Care Only, Custom Insole + Standard Care, TENS + Custom Insole + Standard Care
- Keywords
- Functional Disability, Diabetic Foot Ulcer, Transcutaneous Electrical Nerve Stimulation, Customized Insole, Pain, Dynamic Balance, Risk of Fall, Wound Size, Wound Depth, Diabetes
- Medical subject headings
- Diabetic Foot, Pain, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Care OnlyOther
Standard care includes routine wound debridement, moist wound dressings infection control, glycemic management, vascular assessment, and patient education in line with international DFU management guidelines.
Custom Insole + Standard CareOther
The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.
TENS + Custom Insole + Standard CareOther
Participants in this group will receive a combination of transcutaneous electrical nerve stimulation (TENS), custom-made insole therapy, and standard care for diabetic foot ulcers (DFUs).
| Study group | Role | What they receive |
|---|---|---|
| Standard Care Only | Other | Participants will receive standard care for diabetic foot ulcers. Receives: Other: Standard Care Only |
| Custom Insole + Standard Care | Experimental | Participants will receive a custom insole along with standard care. Receives: Other: Custom Insole + Standard Care |
| TENS + Custom Insole + Standard Care | Experimental | Participants will receive TENS therapy, a custom insole, and standard care. Receives: Other: TENS + Custom Insole + Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
Patients will be assessed for ulcer dimensions by using a simple ruler method. Length and width will be noted using a simple ruler method.
Measured: Wound dimensions will be measured at baseline, and change in length and width will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Secondary outcomes (4)
Risk of fall
The Tinetti Scale will be used to measure the risk of fall. The final score of the scale is 28 points, and the interpretation is as follows: 25-28 = low risk of falls; 19-24 = moderate risk of falls; and <19 = high risk of falls.
Measured: Risk of fall will be measured at baseline, and change in status will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Dynamic Balance:
The time up and go (TUG) scale will be used for measuring dynamic balance. A time score of ≤10 seconds is considered normal, and a time of ≥14 seconds has been shown to indicate a high risk of falls.
Measured: Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.
Pain Intensity
Pain intensity will be measured using a visual analogue scale. It is an 11-point scale where "0" indicates no pain and "10" indicates the worst possible pain.
Measured: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 4th week, 8th week, and 12th week.
Toe Muscle Strength
The paper grip test (PGT) will be used to measure toe muscle strength.
Measured: Toe Muscle Strength will be measured at baseline, and change in strength will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start10 Aug 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jun 2027 (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.
- 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
- Model description
- This is a three-arm parallel-group interventional study designed to evaluate the effects of transcutaneous electrical nerve stimulation (TENS), in addition to custom insoles and standard care, in patients with diabetic foot ulcers (DFUs). Participants will be randomly assigned to one of the following groups: Group 1: Standard care alone Group 2: Standard care + custom insole Group 3: Standard care + custom insole + TENS
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Jamil, University of Lahore
- Investigators
- Prof. Dr. Ashfaq Ahmed, PhD Physiotherapy, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109895
- Sponsor's protocol ID
- Custom Insole with TENS
- Status last verified
- Oct 2026
- First submitted
- 31 Jul 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT07109895
- Acronym / sponsor ID
- Custom Insole with TENS
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Functional Disability, Diabetic Foot Ulcer, Transcutaneous Electrical Nerve Stimulation, Customized Insole, Pain, Dynamic Balance, Risk of Fall, Wound Size
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 10 Aug 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 7 Aug 2025 (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.
Diabetic foot ulcers (DFUs) are one of the serious complications of diabetes, typically resulting from neuropathy or peripheral arterial disease, and can often lead to amputation. It affects approximately 6.3% of people with diabetes globally. In Pakistan, the overall prevalence of DFUs is 16.83%, with a slightly higher rate in females. Diabetic foot ulcers are the main reason for lower extremity amputation (LEA) with non-traumatic origin, hospitalization, healthcare costs, and mortality.
Detailed description
Diabetic foot ulcers (DFUs) are a significant complication of diabetes, carry a high risk of amputation and disability, and affect around 6.3% of diabetic patients globally. Risk factors for DFUs include pre-ulcerative lesions, mechanical pressure, restricted mobility, and poor glycemic control. Peripheral neuropathy plays a crucial role in DFU development, causing structural and functional changes in the foot.
Offloading interventions, such as prefabricated orthotics and custom insoles, are essential for preventing DFU development and promoting ulcer healing. Physiotherapy modalities like therapeutic exercise and electrotherapy can assist in tissue repair and pain management. Orthotic management complements rehabilitation efforts, potentially reducing the risk of wound development. Further research on the combined benefits of transcutaneous electrical nerve stimulation (TENS) and customized insoles for DFUs is necessary to enhance clinical outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- This is a three-arm parallel-group interventional study designed to evaluate the effects of transcutaneous electrical nerve stimulation (TENS), in addition to custom insoles and standard care, in patients with diabetic foot ulcers (DFUs). Participants will be randomly assigned to one of the following groups: Group 1: Standard care alone Group 2: Standard care + custom insole Group 3: Standard care + custom insole + TENS
| Arm | Type | Receives |
|---|---|---|
| Standard Care Only | Other | Other: Standard Care OnlyParticipants will receive standard care for diabetic foot ulcers. |
| Custom Insole + Standard Care | Experimental | Other: Custom Insole + Standard CareParticipants will receive a custom insole along with standard care. |
| TENS + Custom Insole + Standard Care | Experimental | Other: TENS + Custom Insole + Standard CareParticipants will receive TENS therapy, a custom insole, and standard care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥ 18 years old with type 1 and 2 diabetes
- Both Males and Females
- Having Foot ulcers in Grade 1 and Grade 2 according to the Wagner Classification
Key exclusion criteria (10 listed)
- History of amputation (proximal to the trans-metatarsal joint)
- Active or inactive Charcot foot
- Non-constructible peripheral vascular disease secondary to arteriosclerosis (AS)
- Leg length discrepancy
- The presence of any allergic condition of the skin,
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 |
|---|---|---|
| Standard Care OnlyStandard care includes routine wound debridement, moist wound dressings infection control, glycemic management, vascular assessment, and patient education in line with international DFU management guidelines. | Other | Standard Care Only |
| Custom Insole + Standard CareThe experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care. | Other | Custom Insole + Standard Care |
| TENS + Custom Insole + Standard CareParticipants in this group will receive a combination of transcutaneous electrical nerve stimulation (TENS), custom-made insole therapy, and standard care for diabetic foot ulcers (DFUs). | Other | TENS + Custom Insole + Standard Care |
Primary outcome
Wound Healing
Time frame: Wound dimensions will be measured at baseline, and change in length and width will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Patients will be assessed for ulcer dimensions by using a simple ruler method. Length and width will be noted using a simple ruler method.
4 secondary outcomes
Risk of fall
Time frame: Risk of fall will be measured at baseline, and change in status will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Dynamic Balance:
Time frame: Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.
Pain Intensity
Time frame: Pain intensity will be measured at baseline, and change in pain intensity will be measured at 4th week, 8th week, and 12th week.
Toe Muscle Strength
Time frame: Toe Muscle Strength will be measured at baseline, and change in strength will be measured at the 4th week, 8th week, and 12th week of the treatment session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: Yes
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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.
Prof. Dr. Ashfaq Ahmed, PhD Physiotherapy study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Diabetic Foot Ulcer, run by University of Lahore at 1 site in Pakistan.
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 3 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. 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 Pakistan. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayesha Jamil, M.Phil Physiotherapy (+92 324 4481031, ayeshabutt031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound Healing (time frame: Wound dimensions will be measured at baseline, and change in length and width will be measured at the 4th week, 8th week, and 12th week of the treatment session.). 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 9 Oct 2026.