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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

Mar 10, 2016



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 of 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


Purpose

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)

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


Primary outcome(s) - Time of assessment(s)

At recruitment and weekly for 12 weeks


Secondary outcome

  1. Number of ulcers healed by 4 weeks, 8 weeks and 12 weeks in the two groups
  2. Average time taken to complete healing of wounds
  3. Time to reach skin grafting stage for ulcers larger than 12cm2
  4. Size of wound surface area in each week
  5. Degree of pain relief experienced by the patient assessed weekly using a visual analog scale
  6. Identification of adverse effects in both arms

Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Colombo on 21st January 2016 (Ref: EC-15-202)


Funding source

None



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