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

University Hospital, Geneva1 site in 1 country30 target enrollmentJanuary 2010

ConditionsLeg Ulcer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Leg Ulcer
Sponsor: University Hospital, Geneva
Enrollment: 30
Locations: 1
Primary Endpoint: Granulation and /or epithelial tissue progression
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2010

End Date

November 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Geneva

Eligibility Criteria

Inclusion Criteria

•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.