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

Exercise studies with patients with diabetic foot ulcers are very few. In this disease group, since it is considered dangerous to put a load on the foot, a barrier has been placed between the patients and the exercise. With the study investigators plan to do, investigators will try to exercise in these patients in a controlled manner. Among the patients divided into 3 groups, the 1st group will apply the control group, the 2nd group will perform aerobic exercise, and the 3rd group will apply the exercises investigators have determined as the protocol group. 12 weeks, 2 sessions a week will be exercised with the help of a physiotherapist. Patients will be evaluated at baseline, at the end of week 4, at the end of week 8, and at the end.

Conditions

Diabetic Foot Ulcer; Wound

Keywords

diabetes mellitus, exercise, ulcer

Outcome Measures

Primary Outcomes (2)

• ulcer area (mm²)

  Calculation of ulcer area with image j program

  initial assessment- 4th week- 8th week- 12th week

• ulcer depth (mm)

  Ulcer depth measurement with sterile wound stick

  initial assessment - 12th week

Secondary Outcomes (2)

• quality of life score

  initial assessment - 12th week

• sleep quality score

  initial assessment - 12th week

Other Outcomes (1)

• kinesiophobia score

  initial assessment - 12th week

Study Arms (3)

exercise protocol group

EXPERIMENTAL

The group that applied progressive exercise according to the motivation of patients and healing status of ulcers.

Other: exercise protocol

aerobic exercise group

EXPERIMENTAL

The group performing aerobic exercise with a bicycle ergometer

Other: aerobic exercise

control group

EXPERIMENTAL

The group to which standard applications of DFU treatment will be applied

Other: standard treatment

Interventions

standard treatment OTHER

The control group will be provided with the necessary approaches for diabetic foot ulcer care and diaphragmatic breathing exercises.

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: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having been diagnosed with Type II diabetes and having a foot ulcer
• Being in the 1st or 2nd category according to the Wagner classification
• Not to have a serious musculoskeletal, cardiac, neurological, etc. systemic disease that may interfere with the research.
• Not having any communication problems
• Having the same wound care procedure
• Not taking any other treatment that may have an effect on the wound.

You may not qualify if:

• Individuals with a diagnosed psychiatric illness,
• Individuals who have received any physiotherapy treatment in the last 3 months,
• Individuals with acute infection,
• Individuals with toe pressure \< 40 mmHg
• Individuals with Charcot Foot and/or osteomyelitis
• Individuals with venous ulcer disease
• Individuals who are morbidly obese (BMI \>40) according to body mass index
• Individuals with incurable proliperative retinopathy

Sponsors & Collaborators

• Harran University: lead

Study Sites (1)

Harran Unıversıty

Sanliurfa, 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two groups to be applied two different exercises progressing together with the 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 19, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

TU (1)