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

Primary Purpose

Leg Ulcer

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
ApisSept
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leg Ulcer focused on measuring wound healing, granulation tissue, Varicose Ulcer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Home Care Service of the canton of Geneva

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Honey and ionic silver dressing

Arm Description

Outcomes

Primary Outcome Measures

Granulation and /or epithelial tissue progression
Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).

Secondary Outcome Measures

Tolerance
Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.

Full Information

First Posted
April 26, 2010
Last Updated
September 29, 2011
Sponsor
University Hospital, Geneva
Collaborators
Haute école de santé - Genève
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1. Study Identification

Unique Protocol Identification Number
NCT01111695
Brief Title
Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
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 Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva
Collaborators
Haute école de santé - Genève

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leg Ulcer
Keywords
wound healing, granulation tissue, Varicose Ulcer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Honey and ionic silver dressing
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
ApisSept
Intervention Description
honey and ionic silver based dressing
Primary Outcome Measure Information:
Title
Granulation and /or epithelial tissue progression
Description
Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Tolerance
Description
Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Salomon, Dr
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
Home Care Service of the canton of Geneva
City
Geneva
Country
Switzerland

12. IPD Sharing Statement

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

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