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A Study Comparing V.A.C. Negative Pressure Wound Therapy (NPWT) to Moist Wound Therapy (MWT) in the Treatment of Diabetic Foot Amputation Wounds (VAC 2006-19)

Primary Purpose

Diabetic Amputation Foot Wound

Status

Terminated

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

V.A.C. Therapy

Moist wound therapy (MWT)

About this trial

This is an interventional treatment trial for Diabetic Amputation Foot Wound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
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

Exclusion Criteria:

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
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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

V.A.C. Therapy

Moist Wound Therapy (MWT)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of Participants With 100% Wound Closure

Secondary Outcome Measures

Full Information

NCT ID

NCT00837096

First Posted

February 3, 2009

Last Updated

July 29, 2022

Sponsor

1. Study Identification

Unique Protocol Identification Number

NCT00837096

Brief Title

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

Acronym

VAC 2006-19

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Terminated

Why Stopped

Business objectives changed.

Study Start Date

June 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Amputation Foot Wound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

V.A.C. Therapy

Arm Type

Experimental

Arm Description

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.

Arm Title

Moist Wound Therapy (MWT)

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

V.A.C. Therapy

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Moist wound therapy (MWT)

Intervention Description

Gauze Pads, Transparent Films, Hydrogels, Foam, Hydrocolloids, alginate, collagen, and antimicrobial

Primary Outcome Measure Information:

Title

Number of Participants With 100% Wound Closure

Time Frame

Day 84

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 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 Exclusion Criteria: 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 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

Overall Study Officials: