Trial Outcomes & Findings for OASIS Wound Matrix (Oasis) Mechanism of Action (NCT NCT00570141)

NCT ID: NCT00570141

Last Updated: 2011-06-09

Results Overview

Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first. The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment. Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 13 participants
• Primary outcome timeframe: Baseline and weekly up to 12 weeks
• Results posted on: 2011-06-09

Participant Flow

Participant milestones

Measure	OASIS Wound Matrix (Oasis) All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Overall Study STARTED	13
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	OASIS Wound Matrix (Oasis) All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Overall Study Adverse Event	1
Overall Study Missed visits	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

OASIS Wound Matrix (Oasis) Mechanism of Action

Baseline characteristics by cohort

Measure	OASIS Wound Matrix (Oasis) n=13 Participants All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age Continuous	63.5 years STANDARD_DEVIATION 17.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
Wound Type DFU	7 Participants n=5 Participants
Wound Type VSU	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and weekly up to 12 weeks

Population: Analysis was Per Protocol

Wound measurements were made weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.

The final measurement taken was subtracted from the baseline to assess the decrease in wound area after treatment.

Final calculation is mean baseline measurement minus final measurement at 12 weeks (or when wound healed, whichever occurred first)

Outcome measures

Measure	OASIS Wound Matrix (Oasis) n=13 Participants All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. Diabetic Foot Ulcers (DFU)	1.3 cm2 Standard Deviation 0.6
Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. Venous Stasis Ulcers (VSU)	3.6 cm2 Standard Deviation 2.2

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: Analysis was Per Protocol

Wound healing was assessed weekly, spaced 7 +/- 1 day apart, up to 12 weeks or until the wound healed, whichever occurred first.

The outcome value was based on the percent of wounds which were closed at the end of the study (at 12 weeks). The percent wounds closed were calculated for each wound type: Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).

Outcome measures

Measure	OASIS Wound Matrix (Oasis) n=13 Participants All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Percent Wounds Closed Diabetic Foot Ulcers (DFU)	50.0 Percent of Wounds Closed
Percent Wounds Closed Venous Stasis Ulcers (VSU)	66.7 Percent of Wounds Closed

Adverse Events

OASIS Wound Matrix (Oasis)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	OASIS Wound Matrix (Oasis) n=13 participants at risk All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Infections and infestations Follicular swelling	7.7% 1/13 • Number of events 1
Infections and infestations Urinary Tract Infection	7.7% 1/13 • Number of events 1
Infections and infestations Infection left foot 1st metatarsal head	7.7% 1/13 • Number of events 1
Infections and infestations Osteomyelitis left foot 1st metatarsal head	7.7% 1/13 • Number of events 1
Infections and infestations Cellulitis left foot ulcer	7.7% 1/13 • Number of events 1
Injury, poisoning and procedural complications Open wound	7.7% 1/13 • Number of events 1
Injury, poisoning and procedural complications Incision site pain	7.7% 1/13 • Number of events 1
Musculoskeletal and connective tissue disorders Pain in extremity	7.7% 1/13 • Number of events 1
Skin and subcutaneous tissue disorders Blister 2nd toe, left foot, with loose nail	7.7% 1/13 • Number of events 1
Surgical and medical procedures Achilles tendon repair	7.7% 1/13 • Number of events 1
Vascular disorders Ulcer - right foot 5th toe medially	7.7% 1/13 • Number of events 1

Additional Information

Herbert B. Slade, M.D., FAAAI

Healthpoint, Ltd.

Phone: 917-900-4000

Email: bert.slade@healthpoint.com

Results disclosure agreements

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