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.

Launched by MOLNLYCKE HEALTH CARE AB · Mar 18, 2014

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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