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.

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2015

Interventions

  • Device: Fast gelling dressing

Arms, Groups and Cohorts

  • Experimental: Fast Gelling Dressing

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Molnlycke Health Care AB
  • Provider of Information About this Clinical Study
    • Sponsor

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