Last reviewed · How we verify

NCT07270328

A Pilot Study of the Effectiveness of Foot-Ankle and Walking Exercises in Patients With Diabetes Mellitus

Completed NA Last updated 8 December 2025
What this trial tests

NA trial testing Foot-ankle exercise group in Diabete Mellitus in 108 participants. Completed in 30 September 2024.

Timeline
5 July 2024
Primary endpoint
29 September 2024
30 September 2024

Quick facts

Lead sponsorTaipei Medical University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment108
Start date5 July 2024
Primary completion29 September 2024
Estimated completion30 September 2024
Sites3 locations across Indonesia

Drugs / interventions tested

Conditions studied

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:

Other recruiting trials for Diabete Mellitus

Currently open trials in the same condition.

Other Taipei Medical University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07270328.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing