Trial Outcomes & Findings for ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations (NCT NCT01528293)

Results Overview

Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

2 participants

Primary outcome timeframe

6 weeks

Results posted on

2020-03-19

Participant Flow

Participant milestones

Participant milestones
Measure	ActiVAC System+ Compression Therapy ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy. ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week. Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.	Compression Therapy Only Standard of Care compression therapy only ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week. Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ActiV.A.C.+ Compression Therapy Versus Compression Therapy Alone for the Treatment of Chronic Venous Ulcerations

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ActiVAC System+ Compression Therapy n=1 Participants ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy. ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week. Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.	Compression Therapy Only n=1 Participants Standard of Care compression therapy only ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week. Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.	Total n=2 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	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Population: Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.

Wound healing between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 weeks

Population: Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.

-Compare the time to wound bed preparation between the ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 weeks

Population: Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.

Quality of life between ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 Weeks

Population: Enrollment was insufficient to support statistical analyses. Three subjects were screened and only one completed the study.

Degree of split thickness skin graft taken or bioengineered alternative tissue induced wound shrinkage after 6 weeks of ActiV.A.C. System + Compression therapy versus Compression therapy alone in patients with chronic venous ulcerations.

Outcome measures

Outcome data not reported

Adverse Events

ActiVAC System+ Compression Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Compression Therapy Only

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

Paul J. Kim, DPM, Director of Research, MGUH Center for Wound Healing and HBOT

Georgetown University Medical Center

Phone: 202-444-3059

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor can review results communications prior to public release but cannot embargo communications regarding trial results unless those communications are found inaccurate, contain Confidential Information, or would hinder seeking patent protection.
Publication restrictions are in place

Restriction type: OTHER