NCT00349700

Brief Summary

The purpose of the study was to investigated if modern wound dressings adapting to wound exudation and the amount of bacterial colonization can heal large therapy resistant leg ulcers which had a pre-treatment with compresses, ointments and gauze

Trial Health

87
On Track

Trial Health Score

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

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2003

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 7, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 10, 2006

Completed
Last Updated

May 6, 2016

Status Verified

July 1, 2006

First QC Date

July 7, 2006

Last Update Submit

May 5, 2016

Conditions

Varicose Ulcer

Keywords

healingskininfectionwound therapy

Outcome Measures

Primary Outcomes (1)

  • the area of leg ulcers was calculated by multiplication of maximal length and width during the first visit an d at least 6 months after first visit

Interventions

Compression: 2 weeks four layer bandages, then stockingsPROCEDURE
debridementPROCEDURE
Actisorb plus (r) + Trionic(r)/ Allevyn (r)PROCEDURE

Eligibility Criteria

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

You may qualify if:

  • therapy resistant wounds for at least 3 months
  • venous disease
  • uncle pressure \> 80mmHg
  • wound area \> 20qcm

You may not qualify if:

  • uncle pressure \<80mmHg

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Josef Hospital, Dep. Dermatology and Allergology, Ruhr University Bochum

Bochum, 44791, Germany

Location

MeSH Terms

Conditions

Varicose UlcerInfections

Interventions

Debridementallevyn

Condition Hierarchy (Ancestors)

Varicose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerSkin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

  • Peter Altmeyer, Prof. Dr.

    Ruhr University Bochum, Dep. Dermatology and Allergology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2006

First Posted

July 10, 2006

Study Start

January 1, 2003

Study Completion

May 1, 2005

Last Updated

May 6, 2016

Record last verified: 2006-07

Locations

DE(1)