Trial Outcomes & Findings for Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study (NCT NCT01540981)

Last Updated: 2015-01-15

Results Overview

To compare between the treatment groups the effect of the assigned study treatment on the rate of progression of DTI to advanced stage pressure ulcer (Stage III or greater, continued DTI, or a pressure ulcer that is unable to be staged due to necrotic tissue). Stage I - Intact skin with non-blanchable redness of a localized area Stage II - Partial thickness loss of dermis Stage III - Full thickness loss, subcutaneous fat may be visible Stage IV - Full thickness tissue loss with exposed bone, tendon or muscle Unstageable - Full thickness tissue loss in which the base of the ulcer is covered by slough or eschar Continues deep tissue injury - purple or maroon localize area of discolored intact skin that may be mushy or boggy

Recruitment status

TERMINATED

Study phase

Target enrollment

12 participants

Primary outcome timeframe

14 days

Results posted on

2015-01-15

Participant Flow

Participant milestones

Participant milestones
Measure	SOC - Standard of Care Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed	MIST Therapy With SOC Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.
Overall Study STARTED	6	6
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	SOC - Standard of Care Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed	MIST Therapy With SOC Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Deep Tissue Injury Treatment With MIST Therapy Versus Standard Care: REVERSE DTI Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SOC - Standard of Care n=5 Participants Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed	MIST Therapy With SOC n=6 Participants Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.	Total n=11 Participants Total of all reporting groups
Age, Continuous	55 years n=5 Participants	69.5 years n=7 Participants	65 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	11 participants n=5 Participants
BMI	28.6 kilograms per meter squared n=5 Participants	27.7 kilograms per meter squared n=7 Participants	28.6 kilograms per meter squared n=5 Participants
Type of Injury Leading to Suspected DTI Sustained Immobility	1 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants
Type of Injury Leading to Suspected DTI Shearing	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Type of Injury Leading to Suspected DTI Cardiac Arrest/Hemodynamic Crash	1 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants
Type of Injury Leading to Suspected DTI Other	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants
Wound Size	3.8 centimeters squared n=5 Participants	13.9 centimeters squared n=7 Participants	7.4 centimeters squared n=5 Participants
Wound Location Heel	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants
Wound Location Ischium	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Wound Location Sacrum/Coccyx	4 participants n=5 Participants	2 participants n=7 Participants	6 participants n=5 Participants
Wound Location Buttocks	0 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants
Age of Wound	3.0 days n=5 Participants	2.5 days n=7 Participants	3.0 days n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Outcome measures

Outcome measures
Measure	SOC - Standard of Care n=5 Participants Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed	MIST Therapy With SOC n=6 Participants Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.
Effectiveness Pressure Ulcer Stage II	1 participants	1 participants
Effectiveness Unstageable	0 participants	2 participants
Effectiveness DTI	4 participants	2 participants
Effectiveness Healed	0 participants	1 participants

SECONDARY outcome

Timeframe: 14 days

Measured from randomization to last visit (14 days or at discharge from hospital)

Outcome measures

Outcome measures
Measure	SOC - Standard of Care n=5 Participants Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed	MIST Therapy With SOC n=6 Participants Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.
Change in Mean Wound Area	0.94 square centimeters Standard Deviation 6.54	-21.5 square centimeters Standard Deviation 42.4

Adverse Events

SOC - Standard of Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

MIST Therapy With SOC

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

Joyce Black

UNMC

Phone: (402) 559-6573

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place