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

10 Mar 2016

The date of last modification

Jan 29, 2019



Application Summary


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)


Trial Details


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

  1. Male and female patients above 18 years with a single lower limb venous ulcer
  2. Area of ulcer more than 4 cm2 and less than 25cm2
  3. Duration of the ulcer less than 8 weeks
  4. Duplex scan evidence of venous insufficiency demonstrated

Exclusion criteria

  1. Patients who have the following comorbidities:
    a. Occlusive arterial disease – Ankle Brachial Pressure Index (ABPI) below 0.9
    b. Uncontrolled diabetes mellitus with HbA1c > 8% or > 3 or more fasting blood glucose values in the last 6 months > 250mg/dl

    c. Chronic kidney disease Stage III and above
    d. Diagnosed chronic liver disease
    e. Heart failure NYHA class 3 or 4
    f. Diagnosed Vasculitis
    g. Anemia with Hb less than 10g/dL

  2. Recent (< 6 months) varicose vein surgery, laser ablation or sclerotherapy
  3. Ulcers with infection/cellulitis/ osteomyelitis
  4. Current smokers
  5. Patients with history of allergy to phenytoin
  6. Patients with epilepsy who are on oral phenytoin


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



State of Ethics Review Approval


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 & Sponsor Information


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

Trial Completion details


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