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. (CHEXU 01)

Molnlycke Health Care

Status: Completed

Conditions: Diabetic Foot Ulcers

Treatments: Device: Fast gelling dressing

Study type: Interventional

Funder types: Industry

Identifiers

NCT02091778

CHEXU 01

Details and patient eligibility

About

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

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Fast Gelling Dressing

Experimental group

Treatment:

Device: Fast gelling dressing