Venous ulcers in the lower leg.
Conditions
Interventions
Product Name: Phenytoin Sodium Gel
Pharmaceutical Form: Gel
CAS Number: 630-93-3
Concentration unit: % (W/W) percent weight/weight
Concentration type: equal
Concentration number: 5-
Pharmaceutical for
Sponsors
Royal College of Surgeon's Ireland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible subjects MUST comply with the following criteria: 1. Subject must have a venous ulcer in the lower leg with a surface area of at least 5cm2 (as indicated by clinical signs and symptoms of venous ulceration, such as hyperpigmentation of surrounding skin, varicosities, and lipodermatosclerosis). 2. Subject must be more than 18 years old. 3. Absence of significant arterial insufficiency in the affected limb (indicated by an ankle-brachial index of >0.70). 4. Evidence of venous insufficiency on Doppler. 5. Wound must be free of eschar and obvious necrotic tissue. 6. Wounds must be free from cellulites and exudation indicative of heavy bacterial contamination (treatment of bacterial infections with antibiotics prior to commencement is permitted). 7.Provision of a written informed consent prior to enrolment. 8.Agree to avoid pregnancy and not to nurse a child throughout the study (females of child-bearing potential) 9.All females of child bearing potential must have a negative pregnancy test at the Screening Visit and agree to practice a medically acceptable form of contraception (acceptable forms of contraception: hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent) or abstinence, unless surgically sterilised 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: Eligible subjects MUST NOT: 1. Have clinical signs of cellulites. 2. Have clinical signs or history of vasculitis. 3. Have clinical signs or history of collagen vascular diseases. 4. Be pregnant or lactating. 5. Have a history of rheumatoid arthritis. 6. Have sickle cell anaemia. 7. Have uncontrolled diabetes mellitus (subjects with well-controlled diabetes mellitus will be included). 8. Have other clinically significant medical conditions that would impair wound healing, inclusive of renal, hepatic, haematological, neurological, or immunological disease or poor nutritional status (albumin <30g/l). 9. Be receiving corticosteroids, immunosuppressive agents, radiation therapy, or chemotherapy within one month prior to entry into the study. 10. Be receiving phenytoin or nifedipine for the treatment of other conditions. 11. Be receiving drugs that might affect ulcer healing, such as stanazol, paroven, or oxypentifylline. 12. Be currently included in other clinical trials involving investigational medicinal product. 13. Be included in a clinical trial within the previous 4 weeks. 14. Have a history of allergic or hypersensitivity reaction to phenytoin or other constituents of the gel. 15. Have ulcers with exposed bone or tendons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this Phase II clinical trial is to examine the efficacy of phenytoin sodium gel in the treatment of venous ulcers in the lower leg. The IMP will be assessed as an adjunct to compression therapy. The primary endpoint is the measurement of the “time-to-heal” of the treated ulcers. An ulcer is deemed to be healed once complete would closure (epithelialisation) has occurred. ;Secondary Objective: Subjects will also be assessed for a number of secondary endpoints. The ulcer area will be measured using the Visitrak System (Smith and Nephew). Wound area will be compared to the baseline wound area, and also the wound area at the previous visit. Wound area will be expressed as the actual size (cm2) and as the percentage reduction. The rate of healing of the ulcers will also be calculated. The recurrence rate of ulcers will also be monitored throughout the trial. As phenytoin has been reported to reduce pain associated with wounds on which it has been topically applied, the subject’s perception of their pain will be assessed using a visual analogue scale and a numerical 1-10 rating. Histological evaluation of the wound will be conducted to examine the presence of markers of wound healing. ;Primary end point(s): The primary endpoint is the time to closure of the ulcer under investigation. The primary endpoint of this Phase II clinical trial is to examine the efficacy of phenytoin sodium gel in the treatment of venous ulcers in the lower leg. The primary endpoint is the measurement of the “time-to-heal” of the treated ulcers. An ulcer is deemed to be healed once complete would closure (epithelialisation) has occurred. | — |
Countries
Ireland
Outcome results
None listed