Diabetic Amputation Foot WoundVAC 2006-19NCT00837096
A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
A study testing V.A.C. Therapy and Moist wound therapy (MWT) in people with Diabetic Amputation Foot Wound, run by KCI USA, Inc.
Trial summary
The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation. To determine this, measures of healing, quality of life, and utilization costs associated with this approach will be analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Amputation Foot Wound
- What is being tested?
- V.A.C. Therapy and Moist wound therapy (MWT)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Apr 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
- Evidence of therapy controlled diabetes, as defined by the American Diabetes Association (ADA) of HgbA1C ≤10%, within 90 days of screening or at time of screening
- ≥18 years of age
- Forefoot amputation ≤ 8 days old distal to the transmetatarsal level, not extending beyond the Lisfranc's joint
- Receiving MWT allowed in the protocol for treatment of the study wound Protocol: V.A.C. 2006-19 Version 1.10 14 November 2007 Confidential/Proprietary Property of KCI, Inc. 28
- Wound surface area, measured as length x width, of ≥10 cm2
- Subject is willing and able to provide written informed consent, comply with follow-up visit schedule, and maintain a treatment diary
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- Adequate nutrition to enable wound healing as evidenced by a pre-albumin level of
- ≥16 mg/dl or an albumin level of ≥3g/dl within 7 days of screening or at the screening visit
- Adequate perfusion in the affected extremity as evidenced by Grade 1 or 2 PVR waveform as confirmed at screening (see Section 7.1)
- Non-pregnant female Subject of child-bearing potential (confirmed negative by serum hCG), surgically sterilized, or unable to conceive
Who cannot join
- Untreated or refractory cellulitis of the wound with periwound erythema ≥3 cm
- Untreated or refractory osteomyelitis of the wound
- Untreated or refractory infection of the wound
- Exposed blood vessels in or around the wound
- Surgical revascularization of the affected extremity ≤10 days from study enrollment other than by percutaneous means
- Percutaneous revascularization of the affected extremity ≤2 days from study enrollment
Show all 30Show fewer
- Grade 3-5 PVR waveforms
- Long-term (≥30 days) use of steroids (NOTE: Use of non-wound-indicated topical, optical or aerosol types of steroids are permitted at screening and throughout the clinical trial)
- Active Charcot disease of either lower extremity that will interfere with wound treatment
- Malignancy in the wound, around margins or any other malignancy requiring immunosuppressant therapy or chemotherapy
- Presence of necrotic tissue with eschar or slough that cannot be debrided
- Persistent periwound maceration of >96 hours
- Inadequate wound hemostasis that might impair wound healing
- Reported alcohol or drug abuse within the past 6 months
- Topical hypersensitivity or allergy to any disposable component of the V.A.C.® Protocol: V.A.C. 2006-19 Version 1.10 14 November 2007 Confidential/Proprietary Property of KCI, Inc. 29 NPWT System or to tape, dressings, or adhesives
- Female patients with plans to become pregnant during the study period
- Physical (i.e., venous sclerosis) or mental inability to undergo venipuncture for laboratory specimen collection
- Previous participation in this clinical study (VAC 2006-19)
- Participation in any other clinical study ≤30 days of enrollment
- Severe skin conditions (e.g. Meleney's ulcer, scleroderma) that may impair wound healing
- Connective tissue disease or collagen vascular disease (e.g. Ehlers-Danlos syndrome, systemic lupus erythematosus, rheumatoid arthritis) that may impair wound healing
- Hematological disorders or conditions (e.g. polycythemia vera, thrombocythemia, sickle-cell disease) that may impair wound healing
- History of clinically significant chronic anemia as evidenced by a hemoglobin concentration of <10.0 g/dL within ≤30 days of screening
- Severe venous insufficiency (with or without the presence of venous leg ulcers) that may impair wound healing
- Use of V.A.C.® NPWT System to the study wound ≤8 days prior to screening
- Use of any other suction device on the study wound within ≤8 days prior to screening
- Use of normothermic therapy (Warm-UP®) ≤8 days prior to screening
- Use of hyperbaric oxygen therapy (HBO) ≤30 days prior to screening
- Application of recombinant or autologous growth factors (e.g. Regranex® or Procuren®) on the study wound ≤8 days prior to screening
- Application of skin or dermal substitutes and dressings with living cells capable of producing growth factors (e.g. Oasis®, Apligraf®, Dermagraft
About this study
Official title: A Prospective, Randomized, Multicenter, Parallel Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation. To determine this, measures of healing, quality of life, and utilization costs associated with this approach will be analyzed. KCI believes that information obtained from this study will show V.A.C. NPWT can support efforts involving limb salvage of the diabetic foot, helping an effective, cost-efficient healthcare solution.
Read the detailed description
Primary objective is to compare time required to achieve wound bed preparation between Subjects randomized to receive V.A.C. NPWT or MWT. Subjects with ALL the following are eligible for clinical trial enrollment:
Evidence of therapy controlled diabetes, as defined by the American Diabetes Association (ADA) of HbA1C less than or equal to 10%, within 90 days of screen or at time of screening, greater than or equal to 18 years of age, forefoot amputation less than or equal to 10 days old distal to the transmetatarsal level, not extending beyond the Lisfranc joint, receiving MWT allowed in the protocol for treatment of the study wound, Wound surface area measured as length x width of greater than or equal to 10 cm2, Subject is willing and able to provide written informed consent and comply with follow-up visit schedule and maintain a treatment diary, Adequate nutrition to enable wound healing as evidenced by a prealbumin level of greater than or equal to 16 mg/dl or an albumin level of greater than or equal to 3 g/dl within 7 days of screening or at the screening visit, Adequate perfusion in the affected extremity as evidenced by grade 1 or 2 PVR waveform as confirmed at screening, Non-pregnant female Subject of childbearing potential confirmed negative by serum HCG or surgically sterilized or unable to conceive.
- Conditions
- Diabetic Amputation Foot Wound
- Being tested
- V.A.C. Therapy, Moist wound therapy (MWT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
V.A.C. TherapyDevice
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)Device
Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial
| Study group | Role | What they receive |
|---|---|---|
| V.A.C. Therapy | Experimental | 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. Receives: Device: V.A.C. Therapy |
| Moist Wound Therapy (MWT) | Active comparator | 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. Receives: Device: Moist wound therapy (MWT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With 100% Wound Closure
Measured: Day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionApr 2008
Why it stopped: Business objectives changed.
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 Amputation Foot WoundStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Blume, DPM, F.A.C.F.A.S, Principal investigator, North American Center for Limb PreservationBrent Bernstein, DPM, F.A.C.F.A.S, Principal investigator, St. Lukes Allentown & BethlehemMarc Corriveau, M.D., Principal investigator, McGill University Health Centre/Research Institute of the McGill University Health CentreVickie Driver, M.D., Principal investigator, Boston UniversityStephan Elkouri, MD, MSc, FRCSC, FAC, Principal investigator, Centre Hospitalierde l'Universite' de Montreal (CHUM)Luis Esquerdo, DPM, Principal investigator, Esquerdo Podiatric CenterChristopher Gauland, MD, Principal investigator, Eastern Carolina Foot and AnkleVivian Halpern, MD, Principal investigator, North Shore University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837096
- Sponsor's protocol ID
- VAC 2006-19
- Acronym
- VAC 2006-19
- Status last verified
- Oct 2024
- First submitted
- 3 Feb 2009
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- A Prospective, Randomized, Multicenter, Parallel Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds
- ClinicalTrials.gov ID
- NCT00837096
- Acronym / sponsor ID
- VAC 2006-19 / VAC 2006-19
- Conditions
- Diabetic Amputation Foot Wound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives changed.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Posted 19 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to thoroughly examine the role of V.A.C. NPWT in the further salvage of the diabetic foot once it has undergone partial amputation. To determine this, measures of healing, quality of life, and utilization costs associated with this approach will be analyzed. KCI believes that information obtained from this study will show V.A.C. NPWT can support efforts involving limb salvage of the diabetic foot, helping an effective, cost-efficient healthcare solution.
Detailed description
Primary objective is to compare time required to achieve wound bed preparation between Subjects randomized to receive V.A.C. NPWT or MWT. Subjects with ALL the following are eligible for clinical trial enrollment:
Evidence of therapy controlled diabetes, as defined by the American Diabetes Association (ADA) of HbA1C less than or equal to 10%, within 90 days of screen or at time of screening, greater than or equal to 18 years of age, forefoot amputation less than or equal to 10 days old distal to the transmetatarsal level, not extending beyond the Lisfranc joint, receiving MWT allowed in the protocol for treatment of the study wound, Wound surface area measured as length x width of greater than or equal to 10 cm2, Subject is willing and able to provide written informed consent and comply with follow-up visit schedule and maintain a treatment diary, Adequate nutrition to enable wound healing as evidenced by a prealbumin level of greater than or equal to 16 mg/dl or an albumin level of greater than or equal to 3 g/dl within 7 days of screening or at the screening visit, Adequate perfusion in the affected extremity as evidenced by grade 1 or 2 PVR waveform as confirmed at screening, Non-pregnant female Subject of childbearing potential confirmed negative by serum HCG or surgically sterilized or unable to conceive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| V.A.C. Therapy | Experimental | Device: V.A.C. TherapyNegative 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. |
| Moist Wound Therapy (MWT) | Active comparator | Device: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Evidence of therapy controlled diabetes, as defined by the American Diabetes Association (ADA) of HgbA1C ≤10%, within 90 days of screening or at time of screening
- ≥18 years of age
- Forefoot amputation ≤ 8 days old distal to the transmetatarsal level, not extending beyond the Lisfranc's joint
- Receiving MWT allowed in the protocol for treatment of the study wound Protocol: V.A.C. 2006-19 Version 1.10 14 November 2007 Confidential/Proprietary Property of KCI, Inc. 28
- Wound surface area, measured as length x width, of ≥10 cm2
Key exclusion criteria (30 listed)
- Untreated or refractory cellulitis of the wound with periwound erythema ≥3 cm
- Untreated or refractory osteomyelitis of the wound
- Untreated or refractory infection of the wound
- Exposed blood vessels in or around the wound
- Surgical revascularization of the affected extremity ≤10 days from study enrollment other than by percutaneous means
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 |
|---|---|---|
| V.A.C. TherapyNegative 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. | Device | V.A.C. Therapy |
| Moist wound therapy (MWT)Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial | Device | Moist Wound Therapy (MWT) |
Primary outcome
Number of Participants With 100% Wound Closure
Time frame: Day 84
Results and safety
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.
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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, F.A.C.F.A.S principal investigator
North American Center for Limb Preservation
Brent Bernstein, DPM, F.A.C.F.A.S principal investigator
St. Lukes Allentown & Bethlehem
Marc Corriveau, M.D. principal investigator
McGill University Health Centre/Research Institute of the McGill University Health Centre
Questions about this trial
What is this clinical trial studying?
A study testing V.A.C. Therapy and Moist wound therapy (MWT) in people with Diabetic Amputation Foot Wound, 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 30 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: stopped early, 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.
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 19 Dec 2018). 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?
Number of Participants With 100% Wound Closure (time frame: Day 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.