Diabetic Foot UlcersNCT00432965

Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in Diabetic Foot Ulcers

A study testing Moist Wound Therapy and VAC Therapy in people with Diabetic Foot Ulcers, run by KCI USA, Inc at 25 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers. The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Foot Ulcers
What is being tested?: Moist Wound Therapy and VAC Therapy
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 335 participants
Where: 25 sitesin 2 countries
Study dates: May 2002to Mar 2008
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.)
DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E)
Evidence of adequate perfusion by one of the following on the affected extremity,(within the past 60 days):Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or ABIs with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg.
Age ≥ 18 years of age
HbA1c ≤ 12% (collected within the last 90 days.)
Evidence of adequate nutrition by one of the following:
Lab results reflecting Pre-Albumin >16 mg/dl and Albumin level is >3 g/dl (during the seven days prior to the study period), or a nutritional consult will be done and with appropriate supplementation started. Proper documentation on CRFs is needed.

Who cannot join

Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency
Untreated infection or cellulites at site of target ulcer
Presence of untreated osteomyelitis
Collagen vascular disease
Malignancy in the ulcer

Show all 16Show fewer

Presence of necrotic tissue
Uncontrolled hyperglycemia
Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
Open amputations
Prior V.A.C. therapy within 30 days.
Current or prior normothermic (Warm-UP®) or HBO therapy within 30 days.
Current or prior treatment with recombinant or autologous growth factor products within the past 30 days. (Examples: Regranex or Procuren)
Current or prior treatment with skin or dermal substitutes and dressings (Examples: Apligraft, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.
Current use of any enzymatic debridment agent (Example: Acuzyme /Panafil) during the active treatment phase of the study
Pregnant or nursing mothers.

Trial locations and contacts

25 sites in 2 countries.

Country

City, postcode or hospital

25 sites in 2 countries

United States24 sites

Aim Research
Atlanta, Georgia, 30350
Bay Pines VA Medical Center
Bay Pines, Florida, 33744
Podiatric Success, Inc.
Boca Raton, Florida, 33486
Valley Baptist Medical Center
Brownsville, Texas, 78520
Bay Area Foot Care
Castro Valley, California, 94546
Circleville Foot and Ankle, LLC
Circleville, Ohio, 43113
Des Moines University
Des Moines, Iowa, 50312
Banner Health at North Colorado Med. Ctr
Greeley, Colorado, 80634
East Carolina University
Greenville, North Carolina, 27834
Hines VA Hospital
Hines, Illinois, 60141
Innovative Medical Technologies
Los Angeles, California, 90063
North American Center for Limb Preservation
New Haven, Connecticut, 06515
St. Lukes Roosevelt
New York, New York, 10019
North Chicago VAMC
North Chicago, Illinois, 60064
Rosalind Franklin University
North Chicago, Illinois, 60064
Maricopa Medical Center
Phoenix, Arizona, 85008
Hope Research Institute
Phoenix, Arizona, 85015
Robert Wunderlich, DPM
San Antonio, Texas, 78212
Abbott Clinical Research, Inc.
San Antonio, Texas, 78224
Walter F. D Costa
Santa Rosa, California, 95403
Madigan Army Hospital
Tacoma, Washington, 98431
Tucson Vascular Surgery, PLLC
Tucson, Arizona, 85704
Southern Arizona VA Medical Center, Dept. Surgery
Tucson, Arizona, 85723
Genesis Health Care System
Zanesville, Ohio, 43701

Other trials in United States

Canada1 site

St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

Official title: KCI VAC Protocol VAC2001-08, "A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Diabetic Foot Ulcers"

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.

The purpose of this study is to compare the effectiveness of V.A.C.® Therapy to moist wound therapy of diabetic foot ulcers. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure.

Conditions: Diabetic Foot Ulcers
Being tested: Moist Wound Therapy, VAC Therapy
Keywords: Wound closure, Accelerated healing
Medical subject headings: Diabetic Foot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moist Wound TherapyDevice
Moist Wound Therapy (Standard of Care)
VAC TherapyDevice
Also called NPWT
VAC Therapy

Study groups in NCT00432965
Study group	Role	What they receive
VAC Therapy	Experimental	Treatment of Diabetic Foot Ulcers with VAC Therapy Receives: Device: VAC Therapy
Moist Wound Therapy	Active comparator	Moist Wound Therapy (standard of care) Receives: Device: Moist Wound Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of Complete Ulcer Closure Closure.
Measured: Days 0-114

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2002Mar 2008

First posted8 Feb 2007 (estimated)
Study startMay 2002
Primary completionMar 2008
Study completionMar 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Foot UlcersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 335 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00432965
Sponsor's protocol ID: VAC2001-08
Status last verified: Oct 2024
First submitted: 6 Feb 2007
Last updated: 16 Oct 2024
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

All Diabetic Foot Ulcers trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: KCI VAC Protocol VAC2001-08, "A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure Therapy™ in the Treatment and Blinded Evaluation of Diabetic Foot Ulcers"
ClinicalTrials.gov ID: NCT00432965
Acronym / sponsor ID: VAC2001-08
Conditions: Diabetic Foot Ulcers
Keywords: Wound closure, Accelerated healing
Study type: Interventional
Recruitment status: Completed
Enrolment: 335 participants (actual)
Lead sponsor: KCI USA, IncIndustry (pharma, biotech, devices)
Study start: May 2002
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 8 Feb 2007 (estimated)
Results: Posted 13 Nov 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To determine if topical negative pressure therapy delivered by the V.A.C.® device is clinically efficacious and cost effective in the treatment of diabetic foot ulcers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
VAC Therapy	Experimental	Device: VAC TherapyTreatment of Diabetic Foot Ulcers with VAC Therapy
Moist Wound Therapy	Active comparator	Device: Moist Wound TherapyMoist Wound Therapy (standard of care)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Presence of a calcaneal, dorsal or plantar diabetic foot ulcer ≥ 2 cm2 in area after debridement. (If more than one ulcer is present, all wounds will be treated using the same method, but only one ulcer will be studied.)
DFU equivalent to Stage 2 or greater, as defined by Wagner's Scale system (See Appendix E)
Evidence of adequate perfusion by one of the following on the affected extremity,(within the past 60 days):Dorsum transcutaneous oxygen test (TcPO2) with results of ≥30 mmHg, or ABIs with results of ≥0.7 and ≤1.2 and toe pressures with results of ≥30 mmHg, or Doppler arterial waveforms, which are triphasic or biphasic at the ankle in the affected leg.
Age ≥ 18 years of age
HbA1c ≤ 12% (collected within the last 90 days.)

Key exclusion criteria (16 listed)

Patients with recognized active Charcot abnormalities of the foot, as evidence by clinical symptoms that interfere with either randomized treatment group
Ulcers resulting from electrical, chemical, or radiation burns, or venous insufficiency
Untreated infection or cellulites at site of target ulcer
Presence of untreated osteomyelitis
Collagen vascular disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Moist Wound TherapyMoist Wound Therapy (Standard of Care)	Device	Moist Wound Therapy
VAC TherapyAlso: NPWTVAC Therapy	Device	VAC Therapy

Primary outcome

Incidence of Complete Ulcer Closure Closure.
Time frame: Days 0-114

Results and safety

Results posted to the registry on 13 Nov 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VAC Therapy	169	75
Moist Wound Therapy	166	80

Primary outcome: Incidence of Complete Ulcer Closure Closure.

Time frame: Days 0-114. Count of participants. Unit: Participants

Measure	VAC Therapy n = 162	Moist Wound Therapy n = 162
Days 0-7	1	1
Days 8-14	3	2
Days 15-28	8	2
Days 29-42	8	9
Days 43-56	12	11
Days 57-84	21	10
Days 85-114	14	9
Days 0-114	67	44

VAC Therapy vs Moist Wound Therapy: Odds Ratio (OR): 1.89 (95% CI 1.19 to 3.02), p = 0.007, Fisher Exact

Population analysed: Analysis of this endpoint was based on the Intent-to-Treat (ITT population). Subjects who signed an informed consent and were randomized, but failed to undergo their assigned randomized treatment, were included in this population.

Adverse events

Time frame: Through Day 112; for those patients whose wound achieved ulcer closure they were followed through 9 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VAC Therapy	59 of 169 (34.9%)	112 of 169 (66.3%)	4 of 169
Moist Wound Therapy	61 of 166 (36.7%)	71 of 166 (42.8%)	5 of 166

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Foot Ulcers

Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Blume, DPM principal investigator

North American Center for Limb Preservation

25 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Moist Wound Therapy and VAC Therapy in people with Diabetic Foot Ulcers, run by KCI USA, Inc at 25 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Complete Ulcer Closure Closure. (time frame: Days 0-114). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00432965.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.