NCT02091778

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Diabetic Foot Ulcers

Interventions

Type	Name	Description
DEVICE	Fast gelling dressing

Timeline

• Start date: 2014-08-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2014-03-19
• Last updated: 2016-02-23
• Results posted: 2016-02-23

Locations

2 sites across 1 country: United Kingdom