The effectiveness of topical phenytoin on healing varicose ulcers

Phase 3

Conditions: Venous leg ulcers

Registration Number: SLCTR/2016/008

Lead Sponsor: Department of Pharmacology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: Not specified

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of ulcers healed at the end of 12 weeks. Healing will be assessed based on wound surface area <br>• Serial Digital Photographs will be taken by the same observer using a dedicated high resolution digital camera using a predetermined fixed distance.<br>• 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]<br>

Secondary Outcome Measures

Name	Time	Method
umber of ulcers healed by 4 weeks, 8 weeks and 12 weeks in the two groups [At recruitment and weekly for 12 weeks]<br>Average time taken to complete healing of wounds [At recruitment and weekly for 12 weeks]<br>Time to reach skin grafting stage for ulcers larger than 12cm2 [At recruitment and weekly for 12 weeks ]<br>Size of wound surface area in each week [At recruitment and weekly for 12 weeks ]<br>Degree of pain relief experienced by the patient assessed weekly using a visual analog scale [At recruitment and weekly for 12 weeks ]<br>Identification of adverse effects in both arms [At recruitment and weekly for 12 weeks ]<br>