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: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Study Primary Completion Date: March 2015
- Device: Fast gelling dressing
Arms, Groups and Cohorts
- Experimental: Fast Gelling Dressing
Clinical Trial Outcome 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
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.
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
- Lead Sponsor
- Molnlycke Health Care AB
- Provider of Information About this Clinical Study
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