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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01111695
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : September 30, 2011
Haute école de santé - Genève
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Leg Ulcer Device: ApisSept Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2010
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Honey and ionic silver dressing Device: ApisSept
honey and ionic silver based dressing

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01111695

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

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Responsible Party: Dr Denis SALOMON/ Médecin adjoint agrégé, Service de dermatologie - HUG Identifier: NCT01111695     History of Changes
Other Study ID Numbers: CER 09-013
First Posted: April 27, 2010    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: February 2011
Keywords provided by University Hospital, Geneva:
wound healing
granulation tissue
Varicose Ulcer
Additional relevant MeSH terms:
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Leg Ulcer
Skin Ulcer
Skin Diseases