NCT01111695

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

September 30, 2011

Status Verified

February 1, 2011

Enrollment Period

10 months

First QC Date

April 26, 2010

Last Update Submit

September 29, 2011

Conditions

Leg Ulcer

Keywords

wound healinggranulation tissueVaricose Ulcer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Tolerance

    8 weeks

Study Arms (1)

Honey and ionic silver dressing

EXPERIMENTAL
Device: ApisSept

Interventions

ApisSeptDEVICE

honey and ionic silver based dressing

Honey and ionic silver dressing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home Care Service of the canton of Geneva

Geneva, Switzerland

Location

MeSH Terms

Conditions

Leg UlcerVaricose Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVaricose VeinsVascular DiseasesCardiovascular Diseases

Study Officials

  • Denis Salomon, Dr

    University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 27, 2010

Study Start

January 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

September 30, 2011

Record last verified: 2011-02

Locations

CH(1)