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Clinical Trials/NCT05422846
NCT05422846
Completed
Not Applicable

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

Harran University1 site in 1 country51 target enrollmentStarted: August 1, 2022Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
51
Locations
1
Primary Endpoint
ulcer area (mm²)

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
35 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

ulcer area (mm²)

Time Frame: initial assessment- 4th week- 8th week- 12th week

Calculation of ulcer area with image j program

ulcer depth (mm)

Time Frame: initial assessment - 12th week

Ulcer depth measurement with sterile wound stick

Secondary Outcomes

  • quality of life score(initial assessment - 12th week)
  • sleep quality score(initial assessment - 12th week)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Fatih Enzin

Principal Investigator

Harran University

Study Sites (1)

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