Trial Outcomes & Findings for P400 for Stage II-IV Pressure Ulcers in Home and Extended Care (NCT NCT01139879)

Results Overview

The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

12 Weeks

Results posted on

2015-12-17

Participant Flow

Participant milestones

Participant milestones
Measure	P400 All patients will receive the P400 mattress P400 mattress: The P400 mattress will be placed for a period of 12 weeks.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

P400 for Stage II-IV Pressure Ulcers in Home and Extended Care

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	P400 n=10 Participants All patients will receive the P400 mattress P400 mattress: The P400 mattress will be placed for a period of 12 weeks.
Age, Continuous	64.9 years STANDARD_DEVIATION 21.5 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 Weeks

Population: Ulcers decreased an average of 7.96 cm\^2 (+/- 8.1 cm\^2) over the 12 week period

The primary outcome measure for this study is to be healing rate by area, based on the identified target study ulcer.

Outcome measures

Outcome measures
Measure	P400 Support Surface n=29 All Pressure Ulcers All patients will receive the P400 mattress P400 mattress: The P400 mattress will be placed for a period of 12 weeks.
Change From Baseline in Ulcer Surface Area at Week 12	-7.96 cm^2 Standard Deviation 8.1

SECONDARY outcome

Timeframe: 12 Weeks

incidence of new ulcers while on the study surface

Outcome measures

Outcome measures
Measure	P400 Support Surface n=10 Participants All patients will receive the P400 mattress P400 mattress: The P400 mattress will be placed for a period of 12 weeks.
Incidence of New Ulcers	0 percentage of participants

SECONDARY outcome

Timeframe: 12 weeks

Population: Rate of change in area (healing) for all ulcers on all subjects in area (cm\^2)/week

The mean change in area per week for all ulcers

Outcome measures

Outcome measures
Measure	P400 Support Surface n=29 all ulcers All patients will receive the P400 mattress P400 mattress: The P400 mattress will be placed for a period of 12 weeks.
Healing Rate Per Week	-0.92 cm^2/week Standard Deviation .79

Adverse Events

P400 Support Surface

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Randy Wolcott

Wolcott and Associates

Phone: 806-793-8869

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place