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.

Diabetic Foot Ulcers Clinical Trial

— CHEXU 01  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091778
• Other study ID #: CHEXU 01
• Status: Completed
• Phase: N/A
• First received: March 18, 2014
• Last updated: January 26, 2016
• Start date: August 2014
• Est. completion date: March 2015

Study information

• Verified date: March 2014
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcers
• Foot Ulcer
• Ulcer

Intervention

Device:
• Fast gelling dressing

Locations

Country	Name	City	State
United Kingdom	Royal Infirmary of Edinburgh	Edinburgh
United Kingdom	Salford Royal Hospital (NHS) Foundation Trust	Salford

Sponsors (1)

Lead Sponsor	Collaborator
Molnlycke Health Care AB

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 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	12 weeks	No