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Diabetic FootPhase 4NCT00224796

Trial of Vacuum Assisted Closure® Therapy in Amputation Wounds of the Diabetic Foot

A Phase 4 study testing V.A.C. ® System in people with Diabetic Foot, run by KCI USA, Inc.

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

The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Foot
What is being tested?
V.A.C. ® System
Type of treatment
Medical device
How many people
146 participants
Where
No sites listed yet
Study dates
May 2002to Oct 2005
Phase
Phase 4
Are there results?
None posted in the registry

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 diabetic foot amputation wound up to the transmetatarsal region of the foot
  • 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
  • Ankle brachial index (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
Show all 10Show fewer
  • 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 (case report forms)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
  • Wounds resulting from electrical, chemical, or radiation burns, or venous insufficiency
  • Untreated infection or cellulitis at site of target wound
  • Presence of untreated osteomyelitis
  • Collagen vascular disease
  • Malignancy in the wound
Show all 13Show fewer
  • Presence of necrotic tissue in the wound
  • Uncontrolled hyperglycemia
  • Concomitant medications that include (washout period of 30 days for corticosteroids, immunosuppressive medications, or chemotherapy)
  • Prior V.A.C.® therapy within 30 days.
  • Current or prior normothermic (Warm-UP®) or hyperbaric oxygen (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: Apligraf, Dermagraft, or Integra) with living cells capable of producing growth factors (Example: Oasis) within the past 30 days.

About this study

Official title: A Randomized, Controlled Multicenter Trial of Vacuum Assisted Closure® Therapy in the Treatment and Blinded Evaluation of Amputation Wounds of the Diabetic Foot

The purpose of this study is to compare the effectiveness of Vacuum Assisted Closure® (V.A.C.®) Therapy to moist wound therapy of amputation wounds of the diabetic foot. The primary objective is to determine the effect of V.A.C.® Therapy on the incidence of complete wound closure. Secondary objectives include evaluating the acceleration of wound closure, facilitation of surgical closure, incidence of foot salvage, and incidence of wound complications.

Conditions
Diabetic Foot
Being tested
V.A.C. ® System
Keywords
Wound closure, Foot salvage, Accelerated healing, Amputation Wounds of the Diabetic Foot
Medical subject headings
Diabetic Foot

What participants receive

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

  • V.A.C. ® SystemDevice

What is being measured

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

  1. To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.

Secondary outcomes (5)

  1. To determine the effect of V.A.C. ® Therapy on the accelerated wound closure or facilitation of surgical closure

  2. To determine the incidence of foot salvage, as defined by retention of transmetatarsal amputation with no further revisions at end of study

  3. To determine the change in wound area over time

  4. To determine the incidence of complications

  5. To determine the effect of V.A.C. ® Therapy on the quality of life

Timeline

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

  1. First posted23 Sep 2005 (estimated)
  2. Study startMay 2002
  3. Study completionOct 2005

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
146 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00224796
Sponsor's protocol ID
VAC2001-07
Status last verified
Nov 2024
First submitted
21 Sep 2005
Last updated
2 Dec 2024
Results posted
No

Publications

  • Holzer SE, Camerota A, Martens L, Cuerdon T, Crystal-Peters J, Zagari M. Costs and duration of care for lower extremity ulcers in patients with diabetes. Clin Ther. 1998 Jan-Feb;20(1):169-81. doi: 10.1016/s0149-2918(98)80044-1.

    PubMed 9522113

  • Glover JL, Weingarten MS, Buchbinder DS, Poucher RL, Deitrick GA 3rd, Fylling CP. A 4-year outcome-based retrospective study of wound healing and limb salvage in patients with chronic wounds. Adv Wound Care. 1997 Jan-Feb;10(1):33-8.

    PubMed 9204802

  • Bild DE, Selby JV, Sinnock P, Browner WS, Braveman P, Showstack JA. Lower-extremity amputation in people with diabetes. Epidemiology and prevention. Diabetes Care. 1989 Jan;12(1):24-31. doi: 10.2337/diacare.12.1.24.

    PubMed 2714164

  • Morykwas MJ, Argenta LC, Shelton-Brown EI, McGuirt W. Vacuum-assisted closure: a new method for wound control and treatment: animal studies and basic foundation. Ann Plast Surg. 1997 Jun;38(6):553-62. doi: 10.1097/00000637-199706000-00001.

    PubMed 9188970

  • Banwell PE. Topical negative pressure therapy in wound care. J Wound Care. 1999 Feb;8(2):79-84. doi: 10.12968/jowc.1999.8.2.25844. No abstract available.

    PubMed 10232203

  • Mullner T, Mrkonjic L, Kwasny O, Vecsei V. The use of negative pressure to promote the healing of tissue defects: a clinical trial using the vacuum sealing technique. Br J Plast Surg. 1997 Apr;50(3):194-9. doi: 10.1016/s0007-1226(97)91369-2.

    PubMed 9176007

  • Sibbald RG. Venous leg ulcers. Ostomy Wound Manage. 1998 Sep;44(9):52-64; quiz 65-6.

    PubMed 9866605

  • Armstrong DG, Lavery LA; Diabetic Foot Study Consortium. Negative pressure wound therapy after partial diabetic foot amputation: a multicentre, randomised controlled trial. Lancet. 2005 Nov 12;366(9498):1704-10. doi: 10.1016/S0140-6736(05)67695-7.

    PubMed 16291063

  • Armstrong DG, Lavery LA, Boulton AJ. Negative pressure wound therapy via vacuum-assisted closure following partial foot amputation: what is the role of wound chronicity? Int Wound J. 2007 Mar;4(1):79-86. doi: 10.1111/j.1742-481X.2006.00270.x.

    PubMed 17425550

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing V.A.C. ® System in people with Diabetic Foot, run by KCI USA, Inc.

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 10 inclusion and 13 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 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

To determine the effect of V.A.C. ® Therapy on the incidence of complete wound closure.. 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 NCT00224796, which also lists 9 linked publications.

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 2 Dec 2024.

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