Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

University Hospitals (UH)

Status and phase: Completed; Phase 2

Conditions: Leg Ulcer

Treatments: Device: ApisSept

Study type: Interventional

Funder types: Other

Identifiers

NCT01111695

CER 09-013

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Honey and ionic silver dressing

Experimental group

Treatment:

Device: ApisSept