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

NCT05422846 | Completed DMC

• 1 other identifier: diabetic rehabilitation
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Foot Ulcer; Wound

Keywords

diabetes mellitus, exercise, ulcer

Outcome Measures

Primary Outcomes (2)

• ulcer area (mm²)

  Ulcer surface area measured using ImageJ software.

  Baseline, Week 4, Week 8, and Week 12

• ulcer depth (mm)

  Ulcer depth measured with sterile wound stick

  Baseline and Week 12

Secondary Outcomes (2)

• quality of life score

  Baseline and Week 12

• sleep quality score

  initial assessment - 12th week

Other Outcomes (1)

• kinesiophobia score

  Baseline and Week 12

Study Arms (3)

exercise protocol group

EXPERIMENTAL

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

aerobic exercise group

EXPERIMENTAL

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

control group

EXPERIMENTAL

Participants received standard diabetic foot ulcer care according to institutional practice without structured exercise therapy.

Other: standard treatment

Interventions

standard treatment OTHER

Participants received a structured exercise programme supervised by a physiotherapist twice weekly for 12 weeks in addition to standard diabetic foot ulcer care.

Also known as: control

control group

aerobic exercise OTHER

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.

aerobic exercise group

exercise protocol OTHER

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.

exercise protocol group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran Unıversıty

Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Foot; Wounds and Injuries; Diabetes Mellitus; Motor Activity; Ulcer

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned to one of three parallel groups: a structured exercise group, a conventional aerobic exercise group, or a standard care control group.

Study Record Dates

• First Submitted: June 6, 2022
• First Posted: June 21, 2022
• Study Start: August 1, 2022
• Primary Completion: February 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 29, 2026

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)