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Clinical Trials/NL-OMON37546
NL-OMON37546CompletedPhase 4

An open randomised comparative study to evaluate the performance of AQUACEL® Extra* in Venous Leg Ulcers - Assessment of AQUACEL® Extra* on Venous Leg Ulcers

Kaltostat: ConvaTec; Mepilex: Molnlyke Health Care AB0 sites15 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 4
Status
Completed
Sponsor
Enrollment
15
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •The following subjects may be included in the study:;•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
  • •Subjects whose ulcer is no larger than 2cm x 11cm
  • •Subjects who have only one ulcer on the index leg
  • •Subjects* whose index leg ulcer has a moderate to heavy level of exudate (a definition of exudate levels will be provided).
  • •Subjects whose index (study) leg is currently being treated with compression therapy and whose leg oedema is under control
  • •Subjects who are willing and able to comply with the requirements of the clinical investigation plan in relation to the dressing/compression regime and the ability to attend dressing changes as required.

Exclusion Criteria

  • •The following subjects must not be included into the study:;•Subjects with a history of skin sensitivity to any of the components of the study dressings.
  • •Subjects whose wounds are considered clinically infected at baseline
  • •Subjects whose leg is oedematous (level of oedema TBC)
  • •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.

Investigators

Sponsor
Kaltostat: ConvaTec; Mepilex: Molnlyke Health Care AB

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