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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.
Sponsor:
Collaborator:
Haute école de santé - Genève
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01111695
First received: April 26, 2010
Last updated: September 29, 2011
Last verified: February 2011
History of Changes

April 26, 2010
September 29, 2011
January 2010
November 2010   (final data collection date for primary outcome measure)
Granulation and /or epithelial tissue progression [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).
Same as current
Complete list of historical versions of study NCT01111695 on ClinicalTrials.gov Archive Site
Tolerance [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.
Same as current
Not Provided
Not Provided
 
Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
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

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.
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Leg Ulcer
Device: ApisSept
honey and ionic silver based dressing
Experimental: Honey and ionic silver dressing
Intervention: Device: ApisSept
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01111695
CER 09-013
No
Dr Denis SALOMON/ Médecin adjoint agrégé, Service de dermatologie - HUG
University Hospital, Geneva
Haute école de santé - Genève
Principal Investigator: Denis Salomon, Dr Geneva University Hospital
University Hospital, Geneva
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP