The effectiveness of topical phenytoin on healing varicose ulcers

Phase 3

Not yet recruiting

• Conditions: Venous leg ulcers

• Registration Number: SLCTR/2016/008
• Lead Sponsor: Department of Pharmacology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-08-20

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