EASH Dressing on Chronic Venous Leg Ulcers

Leg Ulcer Clinical Trial

Official title:

A Prospective, Multi-centre, Non-comparative Study to Evaluate the Safety and Preliminary Performance of the EASH Dressing on Chronic Venous Leg Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01497210
• Other study ID #: CW-0205-11-U356
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2011
• Last updated: April 24, 2012
• Start date: November 2011
• Est. completion date: April 2012

Study information

• Verified date: April 2012
• Source: ConvaTec Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyPoland: Ethics CommitteePoland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Subjects with a history of skin sensitivity to any of the components of the study product.

• Subjects who have had current local or systemic antibiotics in the week prior to inclusion with the exception of wounds that are considered to be clinically infected at baseline.

• 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 exhibiting any other medical condition which, according to the Investigator, justifies the subject's exclusion from the study

• Subjects who have participated in a clinical study within the past month.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leg Ulcer
• Ulcer
• Varicose Ulcer

Intervention

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

Locations

Country	Name	City	State
Poland	Mikomed	Lodz
Poland	Cross Medica	Warszawa
Poland	Medservice	Zabrze
United Kingdom	Axbridge & Wedmore Medical Practice	Axbridge	Somerset
United Kingdom	Wound Healing Research Unit	Heath Park	Cardiff
United Kingdom	Arrowe Park Hospital	Upton	Wirral

Sponsors (1)

Lead Sponsor	Collaborator
ConvaTec Inc.

Countries where clinical trial is conducted

Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Nature and frequency of adverse events.	All 8 weeks	No
Secondary	Ulcer Improvement (wound bed)		Baseline, week 4 and week 8	No
Secondary	Ulcer Improvement (peri-ulcer)		Baseline, week 4 and week 8 or final visit	No
Secondary	Healing	Reduction in ulcer area	Weekly for 4 weeks then biweekly for 4 weeks or final visit	No
Secondary	Healing	Number of subjects healed	8 weeks or final visit	No
Secondary	Healing	Time to healing	8 weeks or final visit	No
Secondary	Ulcer pain		Weekly for 4 weeks then biweekly for 4 weeks or final visit	No
Secondary	Comfort		Weekly for 4 weeks then biweekly for 4 weeks	No
Secondary	Ease of use		Weekly for 4 weeks then biweekly for 4 weeks	No