Home » Trials » SLCTR/2016/008
The efficacy of topical phenytoin ointment on healing venous leg ulcers: a randomized double blind placebo controlled trial
-
SLCTR Registration Number
SLCTR/2016/008
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
The efficacy of topical phenytoin ointment on healing venous leg ulcers: a randomized double blind placebo controlled trial
Public Title of Trial
The effectiveness of topical phenytoin on healing varicose ulcers
Disease or Health Condition(s) Studied
Venous leg ulcers
Scientific Acronym
None
Public Acronym
None
Brief title
The efficacy of topical phenytoin ointment on healing venous leg ulcers
Universal Trial Number
U1111-1180-3460
Any other number(s) assigned to the trial and issuing authority
EC-15-202 (ERC, Colombo)
What is the research question being addressed?
What is the efficacy of topical phenytoin ointment compared to a placebo when given on top of standard compression bandaging in the healing of venous ulcers?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
The study will be conducted in the vascular clinics of the University Surgical Unit, Faculty of Medicine, Colombo.
Consenting participants meeting the inclusion/exclusion criteria will be randomized using an online random number generator (www.randomisation.com) into two arms.
The intervention arm will receive phenytoin ointment 20mg per 1cm2 of wound surface area applied in a layer and followed by compression bandage. This will be applied weekly for 12 weeks.
The placebo product will contain emulsifying wax, white soft paraffin and liquid paraffin and 20 mg per 1cm2 of wound surface area will applied, followed by compression bandage weekly for 12 weeks.
Both investigators and patients will be blinded to the intervention; the investigators will record the batch number and product investigation number at the time of the use. The details whether each product contain active drug or the placebo will be recorded by the pharmacists in the study team who have no contact with the study participants and no role in assessing outcomes.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Number of ulcers healed at the end of 12 weeks. Healing will be assessed based on wound surface area • Serial Digital Photographs will be taken by the same observer using a dedicated high resolution digital camera using a predetermined fixed distance. • The digital images will be analyzed by ‘ImageJ’ Image processing software and the wound surface area will be measured |
[ At recruitment and weekly for 12 weeks ] |
Secondary outcome(s)
|
1.
Number of ulcers healed by 4 weeks, 8 weeks and 12 weeks in the two groups |
[ At recruitment and weekly for 12 weeks ] |
|
2.
Average time taken to complete healing of wounds |
[ At recruitment and weekly for 12 weeks ] |
|
3.
Time to reach skin grafting stage for ulcers larger than 12cm2 |
[ At recruitment and weekly for 12 weeks ] |
|
4.
Size of wound surface area in each week |
[ At recruitment and weekly for 12 weeks ] |
|
5.
Degree of pain relief experienced by the patient assessed weekly using a visual analog scale |
[ At recruitment and weekly for 12 weeks ] |
|
6.
Identification of adverse effects in both arms |
[ At recruitment and weekly for 12 weeks ] |
Target number/sample size
140 (70 in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2016-03-14
Anticipated end date
2016-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Status
Approved
Date of Approval
2016-01-21
Approval number
EC-15-202
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof. Priyadarshani Galappatthy
Professor
Dept. of Pharmacology
Faculty of Medicine
University of Colombo
0112695300 ext 195
0718655651
0094112697483
p.galappatthy@pharm.cmb.ac.lk
http://www.med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=264
Contact Person for Public Queries
Dr. Sachith Abhayaratna
Lecturer
Dept. of Pharmacology
Faculty of Medicine
University of Colombo
0112695300 ext 195
0773727136
sachithaloka@gmail.com
http://www.med.cmb.ac.lk/index.php/department-of-parmacol-staff?id=268
Primary study sponsor/organization
Department of Pharmacology
Faculty of Medicine University of Colombo
No 25, Kynsey Road, Colombo 0800
Sri Lanka
Tel: 0112695300 ext 195
Web: http://www.med.cmb.ac.lk/index.php/2012-05-16-05-13-13/pharmacology
Secondary study sponsor (If any)
Department of Surgery
Faculty of Medicine Colombo.
No 25, Kynsey Road, Colombo 0800
Sri Lanka
Tel: 0112671846
http://www.med.cmb.ac.lk/index.php/2012-05-16-05-13-13/surgery
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
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
