A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies

• Sponsor: 3M (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00605189
• Collaborator: (none)
• Enrollment: 50
• Locations: 2
• Arms: 3
• Duration (Months): 40
• Patients Per Site: 25
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Foot Ulcers	Device: Powered Suction Pump (VAC Freedom); Device: Powered Suction Pump; Device: MWT	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
• Study Start Date: Jul 1, 2007
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: VAC NPWT	Device: Powered Suction Pump (VAC Freedom); continuous foam based negative pressure wound therapy; Other Names: VAC Freedom
Active Comparator: Gauze-Based NPWT	Device: Powered Suction Pump; continuous gauze based negative pressure wound therapy; Other Names: Gauze-Based Negative Pressure Wound Therapy Device
Active Comparator: Moist Wound Therapy	Device: MWT; moist wound therapy

Outcome Measures

Primary Outcome Measures

1. Compare Energy Charge Between Wound Treatment Therapies [Day 0, Day 2, Day 7]

   Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Type II diabetes

• Subject has a diabetic foot ulcer 5cm squared or greater

• Subject's diabetic foot ulcer is chronic

Exclusion Criteria:

• HgbA1c of 12% or greater

• Presence of cellulitis

• Presence of osteomyelitis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Medical Center	Columbus	Ohio	United States	43210
2	University of Texas Health Science Center San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• 3M

Investigators

• Study Director: Gayle M Gordillo, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: 3M
• ClinicalTrials.gov Identifier: NCT00605189
• Other Study ID Numbers: VACP2005-009
• First Posted: Jan 30, 2008
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Additional relevant MeSH terms: Diabetic Foot; Foot Ulcer

Study Results

Participant Flow

Arm/Group Title	VAC NPWT	Gauze-Based NPWT	Moist Wound Therapy
Arm/Group Description	Powered Suction Pump (VAC Freedom): continuous suction, foam based negative pressure wound therapy	Powered Suction Pump: continuous suction; gauze based negative pressure wound therapy	MWT: moist wound therapy
Period Title: Overall Study
STARTED	20	21	9
COMPLETED	17	19	9
NOT COMPLETED	3	2	0

Baseline Characteristics

Arm/Group Title	VAC NPWT	Gauze-Based NPWT	Moist Wound Therapy	Total
Arm/Group Description	Powered Suction Pump (VAC Freedom): continuous suction	Powered Suction Pump: continuous suction	MWT: moist wound therapy	Total of all reporting groups
Overall Participants	20	21	9	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.6 (9.8)	53.9 (8.4)	56.0 (9.1)	54.1 (9.0)
Sex: Female, Male (Count of Participants)
Female	5 25%	2 9.5%	3 33.3%	10 20%
Male	15 75%	19 90.5%	6 66.7%	40 80%
Race/Ethnicity, Customized (Count of Participants)
African American	1 5%	1 4.8%	0 0%	2 4%
Asian/Pacific Islander	0 0%	1 4.8%	0 0%	1 2%
Caucasian	14 70%	11 52.4%	6 66.7%	31 62%
Hispanic	4 20%	6 28.6%	3 33.3%	13 26%
Other, not specified	1 5%	2 9.5%	0 0%	3 6%
Region of Enrollment (Count of Participants)
United States	20 100%	21 100%	9 100%	50 100%

Outcome Measures

1. Primary Outcome

Title	Compare Energy Charge Between Wound Treatment Therapies
Description	Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate
Time Frame	Day 0, Day 2, Day 7

Outcome Measure Data

Analysis Population Description

Energy charge data was not available for all subjects on the study. Data was only recorded for the subjects listed above.

Arm/Group Title	VAC NPWT	Gauze-Based NPWT	Moist Wound Therapy
Arm/Group Description	Powered Suction Pump (VAC Freedom): continuous suction	Powered Suction Pump: continuous suction	MWT: moist wound therapy
Measure Participants	11	8	9
Day 0	0.4732 (0.0333)	0.5607 (0.1586)	0.4873 (0.0310)
Day 2	0.4601 (0.1399)	0.5535 (0.1377)	0.4927 (0.0379)
Day 7	0.5289 (0.1395)	0.5322 (0.1510)	0.5022 (0.0220)

Adverse Events

Time Frame	30 days
Arm/Group Title	VAC NPWT		Gauze-Based NPWT		Moist Wound Therapy
Arm/Group Description	Powered Suction Pump (VAC Freedom): continuous suction		Powered Suction Pump: continuous suction		MWT: moist wound therapy
All Cause Mortality
	VAC NPWT		Gauze-Based NPWT		Moist Wound Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/20 (0%)		0/21 (0%)		0/9 (0%)
Serious Adverse Events
	VAC NPWT		Gauze-Based NPWT		Moist Wound Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/20 (20%)		1/21 (4.8%)		2/9 (22.2%)
Cardiac disorders
Myocardial Infarction	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Infections and infestations
Osteomyelitis	2/20 (10%)		0/21 (0%)		1/9 (11.1%)
Staphylococcal Infection	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Urinary Tract Infection	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Infected Skin Ulcer	1/20 (5%)		0/21 (0%)		0/9 (0%)
Wound Infection	1/20 (5%)		0/21 (0%)		0/9 (0%)
Cellulitis	0/20 (0%)		1/21 (4.8%)		0/9 (0%)
Investigations
Haemaglobin decreased	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Other (Not Including Serious) Adverse Events
	VAC NPWT		Gauze-Based NPWT		Moist Wound Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/20 (60%)		9/21 (42.9%)		3/9 (33.3%)
Blood and lymphatic system disorders
Anaemia	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Lymphadenopathy	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Cardiac disorders
Atrial Fibrillation	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Cardiomegaly	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Gastrointestinal disorders
Diarrhoea	1/20 (5%)		2/21 (9.5%)		1/9 (11.1%)
Nausea	0/20 (0%)		0/21 (0%)		2/9 (22.2%)
Vomiting	0/20 (0%)		0/21 (0%)		2/9 (22.2%)
Abdominal Pain	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
General disorders
Pyrexia	1/20 (5%)		1/21 (4.8%)		2/9 (22.2%)
Chills	0/20 (0%)		0/21 (0%)		2/9 (22.2%)
Chest Pain	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Infections and infestations
Cellulitis	0/20 (0%)		0/21 (0%)		2/9 (22.2%)
Wound Infection	2/20 (10%)		0/21 (0%)		0/9 (0%)
Localised Infection	1/20 (5%)		0/21 (0%)		0/9 (0%)
Staphylococcal Infection	1/20 (5%)		0/21 (0%)		0/9 (0%)
Injury, poisoning and procedural complications
Wound Complication	2/20 (10%)		3/21 (14.3%)		0/9 (0%)
Excoriation	1/20 (5%)		0/21 (0%)		0/9 (0%)
Foot Fracture	1/20 (5%)		0/21 (0%)		0/9 (0%)
Investigations
International Normalised Ratio Increased	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Urine Output Decreased	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Red Cell Distribution Width Increased	1/20 (5%)		0/21 (0%)		0/9 (0%)
Metabolism and nutrition disorders
Dehydration	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Shock Hypoglycaemic	1/20 (5%)		0/21 (0%)		0/9 (0%)
Musculoskeletal and connective tissue disorders
Pain in Extremity	1/20 (5%)		0/21 (0%)		0/9 (0%)
Nervous system disorders
Dizziness	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Headache	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Renal and urinary disorders
Acute Renal Failure	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Reproductive system and breast disorders
Vaginal Discharge	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Pleural Effusion	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Skin and subcutaneous tissue disorders
Skin Maceration	2/20 (10%)		3/21 (14.3%)		1/9 (11.1%)
Dermatitis	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Night Sweats	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Panniuculitis	0/20 (0%)		0/21 (0%)		1/9 (11.1%)
Rash	1/20 (5%)		0/21 (0%)		0/9 (0%)
Surgical and medical procedures
Wound Drainage	1/20 (5%)		0/21 (0%)		0/9 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.