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Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study

NCT05101473 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-08-10

No results posted yet for this study

Summary

The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT.

The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.

Conditions

  • Diabetic Foot Ulcer
  • Diabetic Foot
  • Wound Healing Disorder
  • Ulcer Foot
  • Ulcer Healing

Interventions

OTHER

Exercise Therapy

The overall framework will consist of two supervised exercise sessions per week of 30-60 min duration for 12 weeks in order to be able to result in the physiological adaptions that are needed to improve the health of the individual participant.

Sponsors & Collaborators

  • Holbaek Sygehus

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2022-04-01
Completion
2022-04-01

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05101473 on ClinicalTrials.gov