N/A
N=24
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
Bottom Line
View on ClinicalTrials.gov: NCT01964521 ↗Enrolled (actual)
24
Serious AEs
29.2%
Results posted
Aug 2018
Primary outcome: Primary: Changes in Signs and Symptoms of Local Infection — 2; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mepilex Transfer Ag (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Molnlycke Health Care AB
- Primary completion
- Apr 2015
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 | — |
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.
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.
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.