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

• Sponsor: University Hospital, Geneva (Other)
• Overall Status: Completed
• CT.gov ID: NCT01111695
• Collaborator: Haute école de santé - Genève (Other)
• Enrollment: 30
• Location: 1
• Arm: 1
• Duration (Months): 10
• Patients Per Site Per Month: 3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leg Ulcer	Device: ApisSept	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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: Jan 1, 2010
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Honey and ionic silver dressing	Device: ApisSept; honey and ionic silver based dressing

Outcome Measures

Primary Outcome Measures

1. Granulation and /or epithelial tissue progression [8 weeks]

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

Secondary Outcome Measures

1. Tolerance [8 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Home Care Service of the canton of Geneva	Geneva		Switzerland

Sponsors and Collaborators

• University Hospital, Geneva
• Haute école de santé - Genève

Investigators

• Principal Investigator: Denis Salomon, Dr, University Hospital, Geneva

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01111695
• Other Study ID Numbers: CER 09-013
• First Posted: Apr 27, 2010
• Last Update Posted: Sep 30, 2011
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: wound healing; granulation tissue; Varicose Ulcer
• Additional relevant MeSH terms: Leg Ulcer

Study Results

No Results Posted as of Sep 30, 2011