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.
CHEXU 01
1 other identifier
interventional
21
1 country
2
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2014
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2014
CompletedFirst Posted
Study publicly available on registry
March 19, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
February 23, 2016
CompletedFebruary 23, 2016
March 1, 2014
7 months
March 18, 2014
January 26, 2016
January 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change in 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
12 weeks
Study Arms (1)
Fast Gelling Dressing
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Royal Infirmary of Edinburgh
Edinburgh, EH16 4SA, United Kingdom
Salford Royal Hospital (NHS) Foundation Trust
Salford, M68hd, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paul Chadwick
- Organization
- Podiatry and Foot health, Stott Lane Salford ,UK
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2014
First Posted
March 19, 2014
Study Start
August 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
February 23, 2016
Results First Posted
February 23, 2016
Record last verified: 2014-03