Custom Insole With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes of Diabetic Foot Ulcers

NCT07109895 | Recruiting DMC

• 1 other identifier: Custom Insole with TENS
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Diabetic Foot Ulcer

Keywords

Functional Disability; Diabetic Foot Ulcer; Transcutaneous Electrical Nerve Stimulation; Customized Insole; Pain; Dynamic Balance; Risk of Fall; Wound Size; Wound Depth; Diabetes

Outcome Measures

Primary Outcomes (3)

• 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.

  Pain intensity will be measured at baseline, and change in pain intensity will be measured at 4th week, 8th week, and 12th week.

• 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.

  Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.

• 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.

  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 (2)

• Risk of fall

  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.

• Toe Muscle Strength

  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.

Study Arms (4)

Standard Care Only

OTHER

Participants will receive standard care for diabetic foot ulcers.

Other: Standard Care Only

Custom Insole + Standard Care

EXPERIMENTAL

Participants will receive a custom insole along with standard care.

Other: Custom Insole + Standard Care

TENS + Custom Insole + Standard Care

EXPERIMENTAL

Participants will receive TENS therapy, a custom insole, and standard care.

Other: TENS + Custom Insole + Standard Care

TENS + Standard Care

EXPERIMENTAL

Participants will receive transcutaneous electrical nerve stimulation (TENS) in addition to standard care.

Other: TENS plus Standard Care

Interventions

Standard Care Only OTHER

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.

Standard Care Only

TENS plus Standard Care OTHER

This experimental group will receive the same intervention plus Transcutaneous Electrical Nerve Stimulation (TENS) in burst mode (1-4 Hz at 100 Hz) applied around the wound site for 30 minutes, along with standard care.

TENS + Standard Care

Custom Insole + Standard Care OTHER

The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.

Custom Insole + Standard Care

TENS + Custom Insole + Standard Care OTHER

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).

TENS + Custom Insole + Standard Care

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,
• 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
• \. Dementia or impaired cognitive function

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

University of Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetic Foot; Pain; Diabetes Mellitus

Interventions

Transcutaneous Electric Nerve Stimulation; Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Prof. Dr. Ashfaq Ahmed, PhD Physiotherapy

  University of Lahore

  STUDY DIRECTOR

Central Study Contacts

Ayesha Jamil, M.Phil Physiotherapy

CONTACT

+92 324 4481031; ayeshabutt031@gmail.com

Maryam Shabbir, PhD Rehabilitation

CONTACT

+92 300 4391550; maryam.shabbir@uipt.uol.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be kept blinded of treatment group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This is a four-arm parallel-group interventional study designed to evaluate the effects of transcutaneous electrical nerve stimulation (TENS), custom insoles, and their combination in addition to 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: TENS + standard care Group 3: Custom insole + standard care Group 4: TENS + custom insole + standard care

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 7, 2025
• Study Start: August 10, 2025
• Primary Completion: January 30, 2026
• Study Completion: January 30, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Will be share after publication

Locations

PA (1)