N/A Completed N=24 Treatment

TITLE: An Open, Non-comparative, Multi-centre Post Marketing Clinical Follow-up (PMCF) Investigation to Evaluate Performance and Safety on Diabetic Foot Ulcer, DFU, When Using Mepilex Transfer Ag as Intended

Diabetic Foot Ulcers

Source: ClinicalTrials.gov NCT01964521 ↗

Enrolled (actual)

Serious AEs

29.2%

Results posted

Aug 2018

Primary outcomePrimary: Changes in Signs and Symptoms of Local Infection — 2; 1; 0 Participants

Summary

An open, non-comparative, multi-centre post marketing clinical follow-up, PMCF, investigation to evaluate performance and safety on diabetic foot ulcer, dfu, when using mepilex transfer Ag as intended.

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Signs and Symptoms of Local Infection	2; 1; 0	—
SECONDARY Levels of Pain in Connection to Dressing Changes.	16; 7.2; 3.5; 4.7; 3.0	—

Eligibility Criteria

Inclusion Criteria

Both gender>=18 years old
Subjects with type 1 or 2 diabetes mellitus
Two of the signs of infection must be present and recorded (redness, heat, oedema, pain, increased exudates amount, deteriorating wound, fever, odour)
Ulcer localization; below the ankle
Signed Informed Consent

Exclusion Criteria

Dry wound
Known allergy/hypersensitivity to the dressing
Treated with other Silver dressing on the ulcer target within 1 week prior to this investigation
Subjects who will have problems following the clinical investigation plan
Subjects enrolled in the investigation already
Subjects included in other ongoing clinical investigation at present or during the past 30 days. Subjects participating in a clinical sample investigation might be enrolled in the investigation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01964521). 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.