Diabetes Mellitus and associated diabetic foot ulceration
Conditions
Interventions
Pharmaceutical Form:
Pharmaceutical form of the placebo: Impregnated dressing
Route of administration of the placebo: Topical use (Noncurrent)
Sponsors
Royal Group of Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study hypothesis is that the application of a topical phenytoin dressing every 2 days will increase the rate of healing in diabetic foot ulcers. The main objective of the study is: 1. To determine the clinical outcomes (positive or negative) in patients with diabetic foot ulceration treated with phenytoin versus placebo including: • % ulcers closed @ 16 weeks • % ulcers closed at specified units of time: 4, 8, 12 weeks • % change in ulcer size @ 4, 8, 12 and 16 weeks ; Secondary Objective: 1. To determine any difference in clinical outcomes in patients with limb ischaemia and diabetic foot ulceration treated with phenytoin versus placebo? Does limb ischaemia limit the effectiveness of this product? 2. To determine whether diabetic foot ulcers +/- treatment with phenytoin more or less likely to recur at 3 and 6 month follow up ;Primary end point(s): The primary endpoint is complete wound closure/epithelialisation. Secondary endpoints will include % reduction in ulcer size, patient withdrawal or withdrawal due to an adverse event. | — |
Countries
United Kingdom
Outcome results
None listed