Home » Trials » SLCTR/2013/017
Effects of leg and foot exercises on ulcer healing in patients with type 2 diabetes mellitus
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SLCTR Registration Number
SLCTR/2013/017
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effects of leg and foot exercises on ulcer healing in patients with type 2 diabetes mellitus
Public Title of Trial
Effect of leg and foot exercises on diabetic foot ulcers
Disease or Health Condition(s) Studied
Diabetic foot ulcers
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
618/12 (Ethics Review Committee of the Faculty of medical Sciences, University of Sri Jayawardenepura)
What is the research question being addressed?
Do foot and leg exercises improve healing of diabetic foot ulcers?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
Patients will be randomized into 2 arms. The intervention arm will be advised to perform non weight bearing leg and foot exercises till the wound is healed or for a maximum period of twelve weeks. Standard therapy such as diabetic diet, oral hypoglycemic drugs/insulin and normal wound care will be continued.
The control group will receive standard therapy only.
Inclusion criteria
1.Wound size not less than 2.5cm 2.Wagner scale 2 & 3 wounds (scale 2 = ulcers extending into tendon, bone, or capsule and scale 3 =deep ulcer with osteomyelitis, or abscess) 3. Duration of ulcer more than one week but not more than 6 months 4. HbA1c level less than 7.5%
Exclusion criteria
Primary outcome(s)
|
1.
|
[ At baseline and every 4 weeks for 12 weeks, and at 12 weeks from the conclusion of the intervention ] |
Secondary outcome(s)
|
1.
None |
[ None ] |
Target number/sample size
140
Countries of recruitment
Sri Lanka
Anticipated start date
2013-05-01
Anticipated end date
2014-09-01
Date of first enrollment
2013-01-05
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
1.University of Sri Jayawardenapura 2.The Open University of Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2012-02-23
Approval number
618/12
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Priyadharshika Hettiarachchi
Professor
Dept. of Physiology,Faculty of Medical Sciences, University of Sri Jayawardenepura.
071 8432344
0112802182, 0112801604
071 8432344
Contact Person for Public Queries
Dr. Sudharshani Wasalathanthri
Senior Lecturer
Department of Physiology, Faculty of Medicine, University of Colombo.
0112695300 0112691581
sudharshaniw@gmail.com
Primary study sponsor/organization
University of Sri Jayawardenapura Gangodawila, Nugegoda
0112758000 0112801024
info@sjp.ac.lk
www.sjp.ac.lk
Secondary study sponsor (If any)
The Open University of Sri Lanka Nawala, Nugegoda.
0112853777 0112806577
www.ou.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
