OASIS Wound Matrix (Oasis) Mechanism of Action

• Sponsor: Healthpoint (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00570141
• Collaborator: (none)
• Enrollment: 13
• Locations: 3
• Arm: 1
• Duration (Months): 30
• Patients Per Site: 4.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

OASIS Wound Matrix (Oasis) will be applied to wounds, with sequential biopsy of healing wounds to explore the mechanism of action.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcers (DFU); Venous Stasis Ulcers (VSU)	Device: OASIS Wound Matrix	Phase 4

Detailed Description

Wound types will be Diabetic Foot Ulcers (DFU) and Venous Stasis Ulcers (VSU).

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Case Study Documentation of Subjects With Either Diabetic Foot Ulcers or Venous Stasis Ulcers Being Treated With OASIS
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Apr 1, 2009
• Actual Study Completion Date: Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: OASIS Wound Matrix (Oasis) This is a single arm study with only the test article Oasis used on all subjects	Device: OASIS Wound Matrix; OASIS (an acellular biomaterial that supports tissue repair with a scaffold-like matrix having a natural structure and composition).

Outcome Measures

Primary Outcome Measures

1. Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First. [Baseline and weekly up to 12 weeks]

   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)

2. Percent Wounds Closed [baseline and 12 weeks]

   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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diabetic foot ulcer (DFU) or venous stasis ulcer (VSU) of the leg, with certain restrictions on size, duration and underlying health

Exclusion Criteria:

• Contraindications or hypersensitivity to the use of the study medications or their components

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sparks Regional Medical Center	Fort Smith	Arkansas	United States	72901
2	Bay Pines VA Healthcare System	St. Louis	Missouri	United States
3	Dixie Regional Medical Center Wound Clinic	St. George	Utah	United States	84770

Sponsors and Collaborators

• Healthpoint

Investigators

• Principal Investigator: W. Payne, M.D., Bay Pines VA Healthcare System
• Principal Investigator: Carl Van Gils, DPM, CWS, Dixie Regional Medical Center Wound Clinic
• Principal Investigator: Davin Haraway, DO, Sparks Regional Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00570141
• Other Study ID Numbers: 9310-002-004
• First Posted: Dec 10, 2007
• Last Update Posted: Jun 9, 2011
• Last Verified: Jun 1, 2011

• Additional relevant MeSH terms: Diabetic Foot; Varicose Ulcer; Foot Ulcer; Ulcer

Study Results

Participant Flow

Arm/Group Title	OASIS Wound Matrix (Oasis)
Arm/Group Description	All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Period Title: Overall Study
STARTED	13
COMPLETED	10
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	OASIS Wound Matrix (Oasis)
Arm/Group Description	All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Overall Participants	13
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	7 53.8%
>=65 years	6 46.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.5 (17.2)
Sex: Female, Male (Count of Participants)
Female	5 38.5%
Male	8 61.5%
Region of Enrollment (participants) [Number]
United States	13 100%
Wound Type (Number) [Number]
DFU	7 53.8%
VSU	6 46.2%

Outcome Measures

1. Primary Outcome

Title	Decrease in Wound Area From Baseline After 12 Weeks of Treatment or Until Wound Closure, Whichever Occurred First.
Description	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)
Time Frame	Baseline and weekly up to 12 weeks

Outcome Measure Data

Analysis Population Description

Analysis was Per Protocol

Arm/Group Title	OASIS Wound Matrix (Oasis)
Arm/Group Description	All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Measure Participants	13
Diabetic Foot Ulcers (DFU)	1.3 (0.6)
Venous Stasis Ulcers (VSU)	3.6 (2.2)

2. Primary Outcome

Title	Percent Wounds Closed
Description	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).
Time Frame	baseline and 12 weeks

Outcome Measure Data

Analysis Population Description

Analysis was Per Protocol

Arm/Group Title	OASIS Wound Matrix (Oasis)
Arm/Group Description	All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
Measure Participants	13
Diabetic Foot Ulcers (DFU)	50.0
Venous Stasis Ulcers (VSU)	66.7

Adverse Events

Arm/Group Title	OASIS Wound Matrix (Oasis)
Arm/Group Description	All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
All Cause Mortality
	OASIS Wound Matrix (Oasis)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	OASIS Wound Matrix (Oasis)
	Affected / at Risk (%)	# Events
Total	0/13 (0%)
Other (Not Including Serious) Adverse Events
	OASIS Wound Matrix (Oasis)
	Affected / at Risk (%)	# Events
Total	6/13 (46.2%)
Infections and infestations
Follicular swelling	1/13 (7.7%)	1
Urinary Tract Infection	1/13 (7.7%)	1
Infection left foot 1st metatarsal head	1/13 (7.7%)	1
Osteomyelitis left foot 1st metatarsal head	1/13 (7.7%)	1
Cellulitis left foot ulcer	1/13 (7.7%)	1
Injury, poisoning and procedural complications
Open wound	1/13 (7.7%)	1
Incision site pain	1/13 (7.7%)	1
Musculoskeletal and connective tissue disorders
Pain in extremity	1/13 (7.7%)	1
Skin and subcutaneous tissue disorders
Blister 2nd toe, left foot, with loose nail	1/13 (7.7%)	1
Surgical and medical procedures
Achilles tendon repair	1/13 (7.7%)	1
Vascular disorders
Ulcer - right foot 5th toe medially	1/13 (7.7%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.