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.

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

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Key information

Conditions

Diabetic Foot Ulcers Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary of Edinburgh, Edinburgh, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
Dry wounds

Treatment and study plan

Fast gelling dressing

Device

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

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Registry information

Acronym: CHEXU 01

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Mar 19, 2014
Registry last updated: Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed