Trial Outcomes & Findings for A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds (NCT NCT00837096)

NCT ID: NCT00837096

Last Updated: 2024-10-16

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 19 participants
• Primary outcome timeframe: Day 84
• Results posted on: 2024-10-16

Participant Flow

Participant milestones

Measure	V.A.C. Therapy Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing. V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.	Moist Wound Therapy (MWT) t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air. Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial
Overall Study STARTED	10	9
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	10	9

Reasons for withdrawal

Measure	V.A.C. Therapy Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing. V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.	Moist Wound Therapy (MWT) t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air. Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial
Overall Study Physician Decision	1	1
Overall Study Not reported	9	8

Baseline Characteristics

A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds

Baseline characteristics by cohort

Measure	V.A.C. Therapy n=10 Participants Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing. V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.	Moist Wound Therapy (MWT) n=9 Participants t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air. Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial	Total n=19 Participants Total of all reporting groups
Age, Continuous	52.9 years STANDARD_DEVIATION 13.15 • n=5 Participants	55.9 years STANDARD_DEVIATION 14.56 • n=7 Participants	55.2 years STANDARD_DEVIATION 12.33 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Other: Arabic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Germany	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 84

Outcome measures

Measure	V.A.C. Therapy n=10 Participants Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing. V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.	Moist Wound Therapy (MWT) n=9 Participants t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air. Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial
Number of Participants With 100% Wound Closure	1 Participants	0 Participants

Adverse Events

V.A.C. Therapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Moist Wound Therapy (MWT)

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	V.A.C. Therapy n=10 participants at risk Negative Pressure Wound Therapy (NPWT) distrubtes negative pressre across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing. V.A.C. Therapy: Negative Pressure Wound Therapy (NPWT) distributes negative pressure across a wound base by means of a specially engineered dressing with the specific intent to help promote wound healing.	Moist Wound Therapy (MWT) n=9 participants at risk t wound therapy (MWT) is a widely used treatment modality that demonstrates benefit through the facilitation of a moist wound environment, which is known to promote faster relative wound healing compared to wounds exposed to air. Moist wound therapy (MWT): Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial
Infections and infestations Osteomyelitis	10.0% 1/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	11.1% 1/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.
General disorders Patient fell at home, transported to ER by EMS	0.00% 0/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	11.1% 1/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.
Infections and infestations Biliary pancreatitis	10.0% 1/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	0.00% 0/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.
Infections and infestations Cellulitis	20.0% 2/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	0.00% 0/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.
Infections and infestations Infected fracture hematoma	10.0% 1/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	0.00% 0/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.
Infections and infestations Influenza	0.00% 0/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	11.1% 1/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.
Infections and infestations Infected ulcer	10.0% 1/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	0.00% 0/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.
General disorders Resuscitation (unknown diagnosis)	10.0% 1/10 • Day 84 Adverse Events were assessed at each protocol scheduled visit.	0.00% 0/9 • Day 84 Adverse Events were assessed at each protocol scheduled visit.

Other adverse events

Adverse event data not reported

Additional Information

VP, Global Clinical Affairs

Acelity

Phone: 210-255-5595

Email: jane.hart@acelity.com

Results disclosure agreements

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

Restriction type: GT60