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Recruiting NCT07109895

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

No phase Interventional Diabetic Foot Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Standard Care Only, TENS plus Standard Care, Custom Insole + Standard Care, TENS + Custom Insole + Standard Care.
Who it may be relevant to
Registry conditions: Diabetic Foot Ulcer. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Effects of a Polyethene-Poron Custom Insole Combined With Transcutaneous Electrical Nerve Stimulation on Clinical Outcomes in Diabetic Foot Ulcers

Overview

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.

Interventions

  • Other Standard Care Only
    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.
  • Other TENS plus Standard Care
    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.
  • Other Custom Insole + Standard Care
    The experimental group will receive customised polyethene foam insoles with a Poron top layer along with standard care.
  • Other TENS + Custom Insole + Standard Care
    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).

Primary outcome measures

  • 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.]
  • Dynamic Balance: [Time frame: Change in status of dynamic balance will be measured at 4th week, at 8th week and 12th week of treatment.]
  • 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.]
Secondary outcome measures (2)
  • 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.]
  • 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.]

Eligibility criteria

Inclusion criteria

  • 18-60 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

Exclusion criteria

  • 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

11\. Dementia or impaired cognitive function

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • University of Lahore — Lahore

Identifiers

NCT: NCT07109895 · Custom Insole with TENS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗