Investigation of the Effects of Different Exercise on Wound Healing in Patients wıth Diabetic Foot Wounds

July 28, 2026 updated by: Fatih Enzin, Harran University

Investigation of the Effect of Different Exercise Training on Wound Healing ın Patients With Diabetic Foot Ulcer

Diabetic foot ulcers are a common complication of diabetes mellitus and are associated with delayed wound healing, impaired quality of life, and an increased risk of lower extremity amputation. Although regular exercise is recommended for people with diabetes, evidence regarding the safety and effectiveness of structured exercise therapy in individuals with diabetic foot ulcers remains limited.

This randomized controlled trial aims to evaluate the effects of two different exercise interventions on wound healing and quality of life in adults with diabetic foot ulcers. Participants are randomly assigned to one of three groups: a structured exercise group, an aerobic exercise group, or a standard care control group. The intervention lasts 12 weeks, with supervised exercise sessions twice weekly. Outcomes, including ulcer surface area, ulcer depth, quality of life, sleep quality, and kinesiophobia, are assessed at baseline, Week 4, Week 8, and Week 12.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Şanlıurfa
      • Sanliurfa, Şanlıurfa, Turkey (Türkiye)
        • Harran Unıversıty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults diagnosed with type 2 diabetes mellitus and presenting with a diabetic foot ulcer.
  • Presence of a Wagner grade 1 or grade 2 diabetic foot ulcer.
  • Absence of severe musculoskeletal, cardiovascular, neurological, or other systemic diseases that could interfere with participation in the study or affect the study outcomes.
  • Ability to communicate effectively and comply with study procedures.
  • Receiving the same standard diabetic foot wound care protocol throughout the study.
  • Not receiving any additional treatment or intervention that could influence wound healing during the study period.

Exclusion Criteria:

  • Individuals with a diagnosed psychiatric disorder.
  • Individuals who have received physiotherapy treatment within the previous 3 months.
  • Individuals with an acute infection.
  • Individuals with a toe pressure <40 mmHg.
  • Individuals diagnosed with Charcot foot and/or osteomyelitis.
  • Individuals with venous leg ulcers.
  • Individuals with morbid obesity (body mass index [BMI] >40 kg/m²).
  • Individuals with proliferative diabetic retinopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: exercise protocol group
Participants received a supervised structured exercise programme tailored to ulcer status and individual physical capacity twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.
Other: exercise protocol
The protocol exercise group will be provided with the necessary approaches for diabetic foot ulcer care and exercises suitable for the physical condition of the wound and the patient, in addition to diaphragmatic breathing exercises. This group will also work with a physiotherapist twice a week.
Experimental: aerobic exercise group
Participants received supervised aerobic exercise using a bicycle ergometer twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.
Other: aerobic exercise
The aerobic exercise group will be provided with the necessary approaches for diabetic foot ulcer care and in addition to diaphragmatic breathing exercises, they will be provided with aerobic exercise twice a week with a physiotherapist.
Experimental: control group
Participants received standard diabetic foot ulcer care according to institutional practice without structured exercise therapy.
Other: standard treatment
Participants received a structured exercise programme supervised by a physiotherapist twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.
Other Names:
  • control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ulcer area (mm²)
Time Frame: Baseline, Week 4, Week 8, and Week 12
Ulcer surface area measured using ImageJ software.
Baseline, Week 4, Week 8, and Week 12
ulcer depth (mm)
Time Frame: Baseline and Week 12
Ulcer depth measured with sterile wound stick
Baseline and Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sleep quality score
Time Frame: initial assessment - 12th week
investigating the sleep quality of patients with the Pittsburgh sleep quality index
initial assessment - 12th week
quality of life score
Time Frame: Baseline and Week 12
Ferrans and Powers Quality of Life Index - Diabetes Version
Baseline and Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
kinesiophobia score
Time Frame: Baseline and Week 12
Tampa Scale for Kinesiophobia
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harran University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

February 1, 2023

Study Completion (Actual)

July 1, 2023

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 21, 2022

Study Record Updates

Last Update Posted (Actual)

July 29, 2026

Last Update Submitted That Met QC Criteria

July 28, 2026

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • diabetic rehabilitation

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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