Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
Phase 2
Completed
- Conditions
- Leg Ulcer
- Interventions
- Device: ApisSept
- Registration Number
- NCT01111695
- Lead Sponsor
- University Hospital, Geneva
- Brief Summary
In this open study, the primary objective is to study the efficacy and clinical outcome of the chronic wounds treated with this preparation for 8 weeks on 30 adults. Evaluation will be based on standardised photographs and clinical data.
The secondary objectives are to evaluate the tolerance and side effects of the honey based preparation in the management of chronic wounds.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Adult
- Chronic wounds due to arterial or venous insufficiency stages 1 to 3 and difficult to heal with the usual treatments and
- Written informed consent
Exclusion Criteria
- Refuse to give written informed consent.
- Patient suffering from mental disorder that may interfere with the treatment.
- Known allergy or intolerance to any of the products used in the formulation.
- Having received systemic antibiotics within 7 days of starting treatment with honey based formulation.
- Arterial insufficiency stage IV of the lower limbs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Honey and ionic silver dressing ApisSept -
- Primary Outcome Measures
Name Time Method Granulation and /or epithelial tissue progression 8 weeks Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).
- Secondary Outcome Measures
Name Time Method Tolerance 8 weeks Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.
Trial Locations
- Locations (1)
Home Care Service of the canton of Geneva
🇨ðŸ‡Geneva, Switzerland