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

This study has been completed.
Haute école de santé - Genève
Information provided by:
University Hospital, Geneva Identifier:
First received: April 26, 2010
Last updated: September 29, 2011
Last verified: February 2011

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.

Condition Intervention Phase
Leg Ulcer Device: ApisSept Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study (Phase 2) to Evaluate the Safety, Tolerance and Efficacy of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs

Resource links provided by NLM:

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Granulation and /or epithelial tissue progression [ Time Frame: 8 weeks ]
    Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).

Secondary Outcome Measures:
  • Tolerance [ Time Frame: 8 weeks ]
    Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.

Estimated Enrollment: 30
Study Start Date: January 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Honey and ionic silver dressing Device: ApisSept
honey and ionic silver based dressing


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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.
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Please refer to this study by its identifier: NCT01111695

Home Care Service of the canton of Geneva
Geneva, Switzerland
Sponsors and Collaborators
University Hospital, Geneva
Haute école de santé - Genève
Principal Investigator: Denis Salomon, Dr Geneva University Hospital
  More Information

Responsible Party: Dr Denis SALOMON/ Médecin adjoint agrégé, Service de dermatologie - HUG Identifier: NCT01111695     History of Changes
Other Study ID Numbers: CER 09-013
Study First Received: April 26, 2010
Last Updated: September 29, 2011

Keywords provided by University Hospital, Geneva:
wound healing
granulation tissue
Varicose Ulcer

Additional relevant MeSH terms:
Leg Ulcer
Skin Ulcer
Skin Diseases processed this record on August 16, 2017