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NCT07270328
A Pilot Study of the Effectiveness of Foot-Ankle and Walking Exercises in Patients With Diabetes Mellitus
NA trial testing Foot-ankle exercise group in Diabete Mellitus in 108 participants. Completed in 30 September 2024.
29 September 2024
Quick facts
| Lead sponsor | Taipei Medical University |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 108 |
| Start date | 5 July 2024 |
| Primary completion | 29 September 2024 |
| Estimated completion | 30 September 2024 |
| Sites | 3 locations across Indonesia |
Drugs / interventions tested
- Foot-ankle exercise group
- Walking exercise group — full drug profile →
- Control group — full drug profile →
Conditions studied
- Diabete Mellitus — all drugs for Diabete Mellitus →
- Diabete Type 2 — all drugs for Diabete Type 2 →
- Diabetic Peripheral Neuropathy — all drugs for Diabetic Peripheral Neuropathy →
- Diabetic Foot — all drugs for Diabetic Foot →
Sponsor
Taipei Medical University
Who can join
Adults 20 to 70, any sex, with Diabete Mellitus or Diabete Type 2. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This pilot feasibility and exploratory study, conducted to prepare for a definitive Randomized Controlled Trial (RCT), compares a structured foot-ankle exercise program with a walking exercise program in adults with Diabetes Mellitus (DM). The primary aim is to assess feasibility, including recruitment rate, retention, adherence, data completeness, acceptability, and adverse events, to inform procedures for the definitive RCT. The secondary (exploratory) aim is to obtain preliminary estimates of effects on Diabetic Peripheral Neuropathy (DPN), stress, and obstacles to Diabetes-Related Quality of Life (DR-QoL), Fasting Blood Glucose (FBG), Body Mass Index (BMI), blood pressure, and Ankle-Brachial Index (ABI). Participants were allocated to three parallel arms for 12 weeks: 1. Foot-ankle exercise (education plus printed materials; independent practice 2-3 sessions/day), 2. Walking exercise (education plus printed materials; ≥150 minutes/week, ≥10 minutes/session, avoiding two consecutive non-exercise days), or 3. Active control (education and printed materials). Outcomes were assessed at baseline (day 0), week 6, and week 12. Analyses focus on feasibility metrics against pre-specified progression criteria and on hypothesis-generating estimates of within- and between-group change in neuropathy, stress, and obstacles to DR-QoL; the study is not powered for definitive efficacy. Retrospective registration note: This study was registered retrospectively after participant enrolment had begun and data collection had been completed. This retrospective status is disclosed for transparency; exploratory outcome analyses are interpreted accordingly, and adverse events related to exercise were monitored and reported.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07270328
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07270328 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Taipei Medical University
- Last refreshed: 8 December 2025
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