NCT01497210

Brief Summary

The primary objective of this study is to evaluate the safety and preliminary performance of EASH dressing for 4 weeks followed by AQUACEL® dressing for 4 weeks on venous leg ulcers.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2011

Shorter than P25 for phase_2

Geographic Reach
2 countries

6 active sites

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

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 20, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

Enrollment Period

5 months

First QC Date

December 20, 2011

Last Update Submit

April 24, 2012

Conditions

Leg Ulcer

Outcome Measures

Primary Outcomes (1)

  • Safety

    Nature and frequency of adverse events.

    All 8 weeks

Secondary Outcomes (8)

  • Ulcer Improvement (wound bed)

    Baseline, week 4 and week 8

  • Ulcer Improvement (peri-ulcer)

    Baseline, week 4 and week 8 or final visit

  • Healing

    Weekly for 4 weeks then biweekly for 4 weeks or final visit

  • Healing

    8 weeks or final visit

  • Healing

    8 weeks or final visit

  • +3 more secondary outcomes

Study Arms (1)

EASH

EXPERIMENTAL
Device: EASH dressing

Interventions

EASH dressingDEVICE

Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.

EASH

Eligibility Criteria

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

You may qualify if:

  • Subjects over 18 years, willing and able to provide written informed consent.
  • Subjects who have an ankle to brachial pressure index (ABPI) of 0.8 or greater
  • Subjects who have a venous leg ulcer (i.e. CEAP classification of C6 1), with duration less than 24 months and size ranging between 5 cm2-40 cm2.
  • Subjects' leg ulcers will meet at least 3 of the 5 following clinical signs of infection: pain between two dressing changes, peri-ulcer skin erythema/inflammation, oedema, malodour (foul odour), and heavy exudate.
  • Subjects who agree to wear compression therapy daily in combination with the trial dressing.

You may not qualify if:

  • Subjects with a history of skin sensitivity to any of the components of the study product.
  • Subjects whose leg ulcers are malignant, or who have had recent deep venous thrombosis or venous surgery within the last 3 months.
  • Subjects who have progressive neoplastic lesion treated by radiotherapy or chemotherapy, or on-going treatment with immunosuppressive agents
  • Subjects who have participated in a clinical study within the past month.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Mikomed

Lodz, Poland

Location

Cross Medica

Warsaw, Poland

Location

Medservice

Zabrze, Poland

Location

Wound Healing Research Unit

Heathpark, Cardiff, CF14 4XN, United Kingdom

Location

Axbridge & Wedmore Medical Practice

Axbridge, Somerset, BS26 2BJ, United Kingdom

Location

Arrowe Park Hospital

Upton, Wirral, CH49 5PE, United Kingdom

Location

MeSH Terms

Conditions

Leg Ulcer

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Keith Harding

    Wound Healing Research Unit, Cardiff University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2011

First Posted

December 22, 2011

Study Start

November 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

April 25, 2012

Record last verified: 2012-04

Locations

PL(3)GB(3)