Evaluation of a Ionic Silver and Honey Preparation to Treat Chronic Wounds of the Lower Legs
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01111695|
Recruitment Status : Completed
First Posted : April 27, 2010
Last Update Posted : September 30, 2011
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 or disease||Intervention/treatment||Phase|
|Leg Ulcer||Device: ApisSept||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2010|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
|Experimental: Honey and ionic silver dressing||
honey and ionic silver based dressing
- Granulation and /or epithelial tissue progression [ Time Frame: 8 weeks ]Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).
- Tolerance [ Time Frame: 8 weeks ]Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01111695
|Home Care Service of the canton of Geneva|
|Principal Investigator:||Denis Salomon, Dr||University Hospital, Geneva|