Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU When Using Fast Gelling Dressing as Intended.

Molnlycke Health Care AB2 sites in 1 country21 target enrollmentAugust 2014

ConditionsDiabetic Foot Ulcers

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetic Foot Ulcers
Sponsor: Molnlycke Health Care AB
Enrollment: 21
Locations: 2
Primary Endpoint: Change in Peri-wound Skin
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this post market clinical follow-up (PMCF) investigation is to evaluate performance and safety of fast gelling dressing when used as intended in Diabetic Foot Ulcer (DFU).

The primary endpoint will be Changes from baseline in the condition of the peri-wound skin measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin

Registry

clinicaltrials.gov

Start Date

August 2014

End Date

March 2015

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Molnlycke Health Care AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Both gender ≥18 years old.
•Subjects with type 1 or 2 diabetes mellitus.
•Texas Grade A1 or 2, C1 or 2
•Exuding diabetic foot ulcer
•Ulcer localisation; below the ankle
•Signed Informed Consent.

Exclusion Criteria

•Known allergy/hypersensitivity to the dressing.
•HbA1c ≥ 10% (86 mmol/mol) (most recent value within 3 months)
•Wound infection requiring systemic treatment
•Subjects who will have problems following the protocol.
•Subjects included in other ongoing clinical investigation at present or during the past 30 days.
•Toe pressure less than 70 mmHg
•Clinical suspicion of osteomyelitis (based on probe to bone/radiological changes)

Outcomes

Primary Outcomes

Change in Peri-wound Skin

Time Frame: 12 weeks

Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin