Trial Outcomes & Findings for 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. (NCT NCT02091778)

NCT ID: NCT02091778

Last Updated: 2016-02-23

Results Overview

Measured by the following variables; maceration, redness/irritation, rash/eczema, blistering, dermatitis, skin stripping, trauma to wound edges and product degradation on the skin

Recruitment status

COMPLETED

Study phase

Target enrollment

21 participants

Primary outcome timeframe

12 weeks

Results posted on

2016-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Fast Gelling Dressing Fast gelling dressing
Overall Study STARTED	21
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fast Gelling Dressing n=21 Participants Fast gelling dressing
Age, Continuous	59.9 years STANDARD_DEVIATION 12.1 • n=99 Participants
Sex: Female, Male Female	0 Participants n=99 Participants
Sex: Female, Male Male	21 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	21 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United Kingdom	21 participants n=99 Participants

PRIMARY outcome

Timeframe: 12 weeks

Population: number of patients with healthy/intact peri-wound skin that increased from baseline to final visit. (From 6 to 14)

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 measures
Measure	Fast Gelling Dressing n=21 Participants Fast gelling dressing
Change in Peri-wound Skin	8 participants

Adverse Events

Fast Gelling Dressing

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fast Gelling Dressing n=21 participants at risk Fast gelling dressing
Endocrine disorders abdominal pain & pain in abdomen.	9.5% 2/21 • Number of events 2
Infections and infestations high temperature and un-well,	4.8% 1/21 • Number of events 1

Other adverse events

Other adverse events
Measure	Fast Gelling Dressing n=21 participants at risk Fast gelling dressing
Infections and infestations Infection to ulcer site,	4.8% 1/21 • Number of events 1

Additional Information

Paul Chadwick

Podiatry and Foot health, Stott Lane Salford ,UK

Phone: 0161 206 4710

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place