Trial Outcomes & Findings for Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury (NCT NCT01433159)

Last Updated: 2014-02-10

Results Overview

Change from baseline in composite wound bed scores measured as the PUSH total score on Day 15. The PUSH Tool v.3.0, which monitors the three critical parameters that are the most indicative of healing, was used in this study. Scales for the three measurements were: Area = 0 (healthy skin) to 10 (\>24 cm x cm); Exudate = 0 (non) to 3 (heavy); Tissue type = 0 (epithelial tissue) to 4 (necrotic tissue). All values were summed and final values are the cumulative scores. Cumulative Scores = 0 (Best possible outcome: healthy skin/epithelial tissue with no exudate) to 17 (Worst possible outcome: wound \>24 cm x cm, containing necrotic tissue, with heavy exudate)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

baseline, 14 Days

Results posted on

2014-02-10

Participant Flow

Subjects \>/= 12 yrs of age with Stage I or II pressure ulcers between 1 and 100 cm2 (inclusive) in total aggregate area and maintaining an adequate nutritional status and were receiving a full caloric diet, either orally or by tube

Participant milestones

Participant milestones
Measure	HP011-101 Xenaderm Ointment	Various Standard Care Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
Overall Study STARTED	9	10
Overall Study COMPLETED	7	9
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	HP011-101 Xenaderm Ointment	Various Standard Care Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
Overall Study Adverse Event	1	0
Overall Study Physician Decision	1	0
Overall Study Protocol Violation	0	1

Baseline Characteristics

Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HP011-101 n=9 Participants Xenaderm Ointment	Various Standard Care n=10 Participants Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Age, Continuous	56.0 years STANDARD_DEVIATION 20.7 • n=5 Participants	58.6 years STANDARD_DEVIATION 18.4 • n=7 Participants	57.4 years STANDARD_DEVIATION 19.0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	10 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline, 14 Days

Population: Per Protocol Population

Outcome measures

Outcome measures
Measure	HP011-101 n=7 Participants Xenaderm Ointment	Various Standard Care n=9 Participants Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
Change From Baseline in Composite PUSH (Pressure Ulcer Scale for Healing) Score	-3.20 scores on a scale Standard Deviation 2.00	-3.47 scores on a scale Standard Deviation 3.73

Adverse Events

HP011-101

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Various Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	HP011-101 n=9 participants at risk Xenaderm Ointment	Various Standard Care n=10 participants at risk Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
Skin and subcutaneous tissue disorders Decubitus ulcer	11.1% 1/9 • Number of events 1 • 21 days	0.00% 0/10 • 21 days

Additional Information

Jaime Dickerson, PhD

Smith & Nephew Biotherapeutics

Phone: 817-302-3914

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60