Trial Outcomes & Findings for Feasibility Study of a Novel Device for Chronic Wounds (NCT NCT00660049)

Results Overview

Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

Baseline up to 31 days

Results posted on

2017-12-13

Participant Flow

Participant milestones

Participant milestones
Measure	SNaP Application This is an "open label" pilot study of SMart Negative Pressure (SNaP) Advanced Wound Care System SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions SNaP: Daily use SNaP: Daily application per protocol
Overall Study STARTED	12
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of a Novel Device for Chronic Wounds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Single Arm Study n=12 Participants Eligible participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants
Age, Continuous	55 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 31 days

Population: All participants

Participants were given instructions to use the SNaP device home. Participants completed a questionnaire reporting whether the device was easy to use, worthwhile to use, and whether they would use the device again. Numbers responding positively to each question are presented.

Outcome measures

Outcome measures
Measure	Open Label Single Arm Study n=12 Participants All participants who use the device
Ease of Use for Patients Easy to use	8 participants
Ease of Use for Patients Worthwhile to use	10 participants
Ease of Use for Patients I would use this device again	9 participants

Adverse Events

Eligible Participants

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Eligible Participants n=12 participants at risk This is an "open label" pilot study of SNaP Advanced Wound Care System SNaP Advanced Wound Care System: Application of negative pressure device daily per instructions SNaP: Daily use SNaP: Daily application per protocol
Skin and subcutaneous tissue disorders wound pain	25.0% 3/12 • 1 month
Musculoskeletal and connective tissue disorders ipsilateral knee pain	27.3% 3/11 • 1 month

Additional Information

Anne Chang, MD

Stanford University

Phone: (650) 721 7151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60