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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
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01111695

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

No publications provided

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

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

Additional relevant MeSH terms:
Leg Ulcer
Ulcer
Skin Ulcer
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013