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

Leg Ulcer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111695
• Other study ID #: CER 09-013
• Status: Completed
• Phase: Phase 2
• First received: April 26, 2010
• Last updated: September 29, 2011
• Start date: January 2010
• Est. completion date: November 2010

Study information

• Verified date: February 2011
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer

Intervention

Device:
• ApisSept
honey and ionic silver based dressing

Locations

Country	Name	City	State
Switzerland	Home Care Service of the canton of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Haute école de santé - Genève

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Granulation and /or epithelial tissue progression	Granulation and /or epithelial tissue progression as observed by standardised photography (colour-based and analysis of the wound).	8 weeks	No
Secondary	Tolerance	Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.	8 weeks	Yes