Diabetic Foot UlcersNCT00847730
Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Wound Therapy
A study testing V.A.C. Negative Pressure Wound Therapy System in people with Diabetic Foot Ulcers, run by KCI USA, Inc at 6 sites in United States.
Trial summary
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear. 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?
- V.A.C. Negative Pressure Wound Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesUnited States
- Study dates
- Feb 2009to Sep 2009
- 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
- Male or Female subjects must be ≥ 18 years of age
- Subject is willing and able to provide written informed consent and comply with protocol required procedures
- Subject has a calcaneal, dorsal or plantar diabetic foot ulcer no greater than a Grade 2 on the Wagner Grading System for which ActiV.A.C.® Therapy has been prescribed and requires off loading of the SensaT.R.A.C. PadTM
- Subject has a foot ulcer that is ≥ 1.5cm2 but no greater than 84 cm2
- Female subject that is willing to use an effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. Acceptable means of contraception is defined as use of Birth control pills, Depo Provera® , Norplant® , IUD (intrauterine device), Diaphragm with spermicide, Condom with spermicide
Who cannot join
- Subject's wound measures > 84 cm2
- Presence of untreated cellulitis
- Presence of untreated or refractory osteomyelitis (including untreated necrotic bone, non-viable tissue and infected bone)
- History of radiation to the wound area
- History of thermal injury in the wound area
- Known hypersensitivity to any disposable component of the V.A.C.® Therapy system
Show all 12Show fewer
- Necrotic tissue with eschar present that cannot be debrided prior to subject enrollment in the study
- Subject is exhibiting active signs and symptoms of infection of the wound(i.e. increased redness or erythema, increased pain, warmth, purulent drainage)
- Past or current enrollment in this clinical study or any other clinical study within 30 days
- Female Subject who is pregnant or is unwilling to use acceptable means of contraception during the duration of her participation in the study
- Subject exhibits significant peri-wound issues that in the opinion of the investigator can interfere with the study assessments
- Subject is unable to co-operate with study assessments or has a history of non-compliance with off-loading modalities or has a foot deformity that in the opinion of the investigator does not allow for appropriate dressing application or off loading placement.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Key Stone Medical Research Associates
Bethlehem, Pennsylvania, 18018
North American Center for Limb Preservation
New Haven, Connecticut, 06515
Alamo Clinical Research Consultants
San Antonio, Texas, 78212
Alamo Family Foot and Ankle Care
San Antonio, Texas, 78258
Drs Research Network
South Miami, Florida, 33143
Scott and White Dept of Surgery
Temple, Texas, 76508
About this study
Official title: A Single Arm, Prospective Clinical Trial Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Therapy
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
Read the detailed description
The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- V.A.C. Negative Pressure Wound Therapy System
- Keywords
- Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy
- 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. Negative Pressure Wound Therapy SystemDevice
This is a non-invasive wound treatment system that uses controlled, localized negative pressure to create an environment that promotes wound healing in chronic and acute wounds
| Study group | Role | What they receive |
|---|---|---|
| VAC GranuFoam Bridge Dressing | Experimental | This is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours. Receives: Device: V.A.C. Negative Pressure Wound Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of Use Assessment
Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes.
Measured: 48-72 hours (+6 hours) time period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2009
- Study completionSep 2009
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00847730
- Sponsor's protocol ID
- VACDrsg 2008-37
- Status last verified
- Oct 2024
- First submitted
- 17 Feb 2009
- Last updated
- 16 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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 Single Arm, Prospective Clinical Trial Evaluating the Ease of Use of a VAC GranuFoam Bridge Dressing on Diabetic Foot Ulcers Receiving VAC Negative Pressure Therapy
- ClinicalTrials.gov ID
- NCT00847730
- Acronym / sponsor ID
- VACDrsg 2008-37
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Ease of dressing application, dressing conformability and ease of dressing removal on diabetic foot ulcers using the ActiVAC therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Posted 16 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is aimed at evaluating the clinician's perceived ease of using the V.A.C. GranuForm bride dressing and the patients perceived level of comfort during the dressing wear.
Detailed description
The objective of this study is to evaluate the ease of use of the V.A.C® GranuFoam™ Bridge dressing on Diabetic Foot Ulcers under ActiV.A.C® negative pressure wound therapy for a period of 48-72 hrs (+6hrs). Ease of use will be determined based on the feedback on the following characteristics 1) Ease of dressing application 2) Ease of dressing removal and 3) Ease of dressing conformability. Additionally patient feedback on comfort during wear will also be collected. Patients currently prescribed to V.A.C.® Therapy will be enrolled in the trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAC GranuFoam Bridge Dressing | Experimental | Device: V.A.C. Negative Pressure Wound Therapy SystemThis is a medical device foam dressing allowing placement away from wound site. It is designed to simplify the bridging application. It is used in combination with the V.A.C. Negative Pressure Wound Therapy System. For each subject, the dressing was applied in compliance with the IFU for 48-72 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female subjects must be ≥ 18 years of age
- Subject is willing and able to provide written informed consent and comply with protocol required procedures
- Subject has a calcaneal, dorsal or plantar diabetic foot ulcer no greater than a Grade 2 on the Wagner Grading System for which ActiV.A.C.® Therapy has been prescribed and requires off loading of the SensaT.R.A.C. PadTM
- Subject has a foot ulcer that is ≥ 1.5cm2 but no greater than 84 cm2
- Female subject that is willing to use an effective method of contraception for the duration of the study, is permanently sterilized, or post-menopausal as defined by cessation of menses for at least twelve (12) months prior to enrollment. Acceptable means of contraception is defined as use of Birth control pills, Depo Provera® , Norplant® , IUD (intrauterine device), Diaphragm with spermicide, Condom with spermicide
Key exclusion criteria (12 listed)
- Subject's wound measures > 84 cm2
- Presence of untreated cellulitis
- Presence of untreated or refractory osteomyelitis (including untreated necrotic bone, non-viable tissue and infected bone)
- History of radiation to the wound area
- History of thermal injury in the wound area
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. Negative Pressure Wound Therapy SystemThis is a non-invasive wound treatment system that uses controlled, localized negative pressure to create an environment that promotes wound healing in chronic and acute wounds | Device | VAC GranuFoam Bridge Dressing |
Primary outcome
Ease of Use Assessment
Time frame: 48-72 hours (+6 hours) time period
Each subject was assessed on the three scales (each scale was 1-Poor, 2 - Fair, 3 - Good, 4 - Excellent) and given a score on each individual characteristic (Ease of Dressing Application, Ease of Conformability, and Ease of Dressing Removal). The scores were then summed for each subject with possible range being 3-12. If the subject had a total score greater than or equal to 6, and a minimum score of greater than or equal to 2 on each individual characteristic then the subject was included in the percentage of subjects with satisfactory performance. Note that for each scale higher scores indicate better outcomes.
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.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing V.A.C. Negative Pressure Wound Therapy System in people with Diabetic Foot Ulcers, run by KCI USA, Inc at 6 sites in United States.
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 5 inclusion and 12 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 6 sites in United States. 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 16 Jul 2019). 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?
Ease of Use Assessment (time frame: 48-72 hours (+6 hours) time period). 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.