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

NCT ID: NCT01111695

Last Updated: 2011-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Leg Ulcer

Keywords

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wound healing granulation tissue Varicose Ulcer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Honey and ionic silver dressing

Group Type EXPERIMENTAL

ApisSept

Intervention Type DEVICE

honey and ionic silver based dressing

Interventions

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ApisSept

honey and ionic silver based dressing

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haute école de santé - Genève

UNKNOWN

Sponsor Role collaborator

University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Service de dermatologie - HUG

Principal Investigators

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Denis Salomon, Dr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Home Care Service of the canton of Geneva

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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CER 09-013

Identifier Type: -

Identifier Source: org_study_id