Trial Outcomes & Findings for 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 (NCT NCT01964521)

NCT ID: NCT01964521

Last Updated: 2018-08-10

Results Overview

Evaluation of signs of infection (exudate) from baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 24 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2018-08-10

Participant Flow

Participant milestones

Measure	Mepilex Transfer Ag Mepilex Transfer Ag is a transfer dressing designed for low to high exuding wounds and used to prevent microbial growth. It is worn for up to two weeks at a time.
Overall Study STARTED	24
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Mepilex Transfer Ag Mepilex Transfer Ag is a transfer dressing designed for low to high exuding wounds and used to prevent microbial growth. It is worn for up to two weeks at a time.
Overall Study Lost to Follow-up	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Mepilex Transfer Ag n=24 Participants An open, non-comparative study.
Age, Continuous	61.1 years STANDARD_DEVIATION 12.6 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Population: ITT

Evaluation of signs of infection (exudate) from baseline

Outcome measures

Measure	Mepilex Transfer Ag n=24 Participants An open, non-comparative study.
Changes in Signs and Symptoms of Local Infection Week 1 Exudate amount - worsening compared to base	2 Participants
Changes in Signs and Symptoms of Local Infection Week 2 Exudate amount - worsening compared to base	1 Participants
Changes in Signs and Symptoms of Local Infection Week 4 Exudate amount - worsening compared to base	0 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: For some patients pain assessment was not performed at all predefined timepoints. Therefore some data were not collected.

Levels of pain measured by VAS, visual analog scale. 1 to 100 mm, 1= low pain, 100= worse pain.

Outcome measures

Measure	Mepilex Transfer Ag n=24 Participants An open, non-comparative study.
Levels of Pain in Connection to Dressing Changes. Baseline	16 units on a scale Standard Deviation 24.4
Levels of Pain in Connection to Dressing Changes. Week 1	7.2 units on a scale Standard Deviation 14.3
Levels of Pain in Connection to Dressing Changes. Week 2	3.5 units on a scale Standard Deviation 4.9
Levels of Pain in Connection to Dressing Changes. Week 3	4.7 units on a scale Standard Deviation 9.8
Levels of Pain in Connection to Dressing Changes. Week 4	3.0 units on a scale Standard Deviation 4.1

Adverse Events

Mepilex Transfer Ag

Serious events: 7 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Mepilex Transfer Ag n=24 participants at risk An open, non-comparative study.
General disorders pulmonary embolism	4.2% 1/24 • Number of events 1
General disorders psuedo-gout of wrist	4.2% 1/24 • Number of events 1
Infections and infestations wound infection	12.5% 3/24 • Number of events 3
General disorders Wound deterioration	8.3% 2/24 • Number of events 2

Other adverse events

Measure	Mepilex Transfer Ag n=24 participants at risk An open, non-comparative study.
General disorders ankle pain	4.2% 1/24 • Number of events 24

Additional Information

Dr Ketan Dhatariya

The Norfolk & Norwich University Hospitals NHS Foundation Trust

Phone: +44 1603 286286

Email: ketan.dhatariya@nnuh.nhs.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60