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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Jan 30, 2026 → Dec 30, 2026
Primary endpoints removed 3 → 1 primary endpoints
See other at-risk trials from University of Lahore

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Jan 30, 2026 to Dec 30, 2026 Show 7 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 40 → 159 participants
    • Study completion pushed from Jan 30, 2026 to Jun 30, 2027
    • Interventions modified
    • Trial arms changed: 4 → 3
    • Eligibility criteria expanded, about 13 words
    • Secondary endpoints: 2 to 4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 1, 2025 to Aug 10, 2025
    • Secondary endpoints: details revised at 1 of 2 entries
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Lahore
103 trials monitored
See 3 trials at risk
Diabetes
5,087 trials monitored
See 222 trials at risk
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.
Trial Details
NCT Number NCT07109895
Lead Sponsor University of Lahore
Conditions
(from sponsor)		 Diabetic Foot Ulcer
Related terms Diabetes Mellitus, Diabetic Foot, Pain
Enrollment 159 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov