N/A Completed N=21 Treatment

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

Source: ClinicalTrials.gov NCT02091778 ↗

Enrolled (actual)

Serious AEs

9.5%

Results posted

Feb 2016

Primary outcomePrimary: Change in Peri-wound Skin — 8 participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Peri-wound Skin	8	—

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02091778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.