Leg Ulcer
Conditions
Keywords
wound healing, granulation tissue, Varicose Ulcer
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.
Interventions
DEVICEApisSept
honey and ionic silver based dressing
Sponsors
Haute école de santé - Genève
University Hospital, Geneva
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Tolerance | 8 weeks | Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation. |
Countries
Switzerland
Outcome results
None listed