Evaluation of a Ionic Silver and Honey Preparation to Tre... | NCT01111695

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

NCT01111695

Sponsor

University Hospital, Geneva

Status

Completed

Last Update Posted

Sep 30, 2011Estimated

Enrollment

30Estimated

Phase

Phase 2

Conditions

Leg Ulcer

Interventions

ApisSept

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Apr 26, 2010

First Submission Date that Met QC Criteria

Apr 26, 2010

First Posted Date

Apr 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 29, 2011

Last Update Posted Date

Sep 30, 2011Estimated

Name	Class
Haute école de santé - Genève	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Honey and ionic silver dressing	Experimental		Device: ApisSept

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ApisSept	Device	honey and ionic silver based dressing	Honey and ionic silver dressing

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
Tolerance	Tolerance: Evaluate for signs and symptoms of irritation,inflammation, allergy or pain in and around the treated zone by clinical observation.	8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Denis Salomon, Dr	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Home Care Service of the canton of Geneva		Geneva			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D007871	Leg Ulcer
D014647	Varicose Ulcer

Ancestor Terms

ID	Term
D012883	Skin Ulcer
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D014648	Varicose Veins

Browse Leaves

Not provided

Browse Branches

Not provided