A double blind, prospective, randomised, controlled clinical trial to evaluate the effect of topical phenytoin, on healing, in diabetic foot ulcers. - none

Phase 1

• Conditions: Diabetes Mellitus and associated diabetic foot ulceration

• Registration Number: EUCTR2004-004787-74-GB
• Lead Sponsor: Royal Group of Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-02-23
• Study Completion: 2008-12-01
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 144

Inclusion Criteria

Age: At least 18 years of age.

2.Gender: Males and females

3.Patients presenting with Type 1 or Type 2 diabetes

4.Foot ulcer / wound of at least 4 weeks duration

5.Stable vascular status –
Ankle Brachial Pressure Index > 0.4
No acute ischaemia / rest pain
No necrosis or gangrene
Post vascular reconstruction

6. Evidence of neuropathy - VPT’s greater than 25 volts
Diminished sensation to 10g monofilament
Reduced blunt / sharp discrimination

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Acute ischaemia / rest pain/ necrosis or gangrene (of the wound) - ABPI < 0.4

2.Worsening claudication

3.Worsening clinical infection, cellulitis, amputation

4.Patient unwilling to participate in study

5.Patients who have significant hepatic or end stage renal disease

6.Patients who have malignant disease

7.Pregnancy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified