Diabetic Foot UlcersNCT00605189
A Trial Examining Cellular Energetics Related to Various Wound Treatment Therapies
A study testing Powered Suction Pump (VAC Freedom), Powered Suction Pump and MWT in people with Diabetic Foot Ulcers, run by KCI USA, Inc at 2 sites in United States.
Trial summary
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with 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?
- Powered Suction Pump (VAC Freedom), Powered Suction Pump and MWT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Nov 2010
- 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
- Type II diabetes
- Subject has a diabetic foot ulcer 5cm squared or greater
- Subject's diabetic foot ulcer is chronic
Who cannot join
- HgbA1c of 12% or greater
- Presence of cellulitis
- Presence of osteomyelitis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Medical Center
Columbus, Ohio, 43210
University of Texas Health Science Center San Antonio
San Antonio, Texas, 78229
About this study
Official title: A Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- Powered Suction Pump (VAC Freedom), Powered Suction Pump, MWT
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powered Suction Pump (VAC Freedom)Device
Also called VAC Freedom
continuous foam based negative pressure wound therapy
Powered Suction PumpDevice
Also called Gauze-Based Negative Pressure Wound Therapy Device
continuous gauze based negative pressure wound therapy
MWTDevice
moist wound therapy
| Study group | Role | What they receive |
|---|---|---|
| VAC NPWT | Active comparator | Not described Receives: Device: Powered Suction Pump (VAC Freedom) |
| Gauze-Based NPWT | Active comparator | Not described Receives: Device: Powered Suction Pump |
| Moist Wound Therapy | Active comparator | Not described Receives: Device: MWT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare Energy Charge Between Wound Treatment Therapies
Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit.
Energy Charge is calculated as follows:
Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP)
Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate
Measured: Day 0, Day 2, Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2008 (estimated)
- Study startJul 2007
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: Study no longer met business objectives
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- KCI USA, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gayle M Gordillo, MD, Study director, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00605189
- Sponsor's protocol ID
- VACP2005-009
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2007
- 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 Randomized, Controlled Trial Examining Cellular Energetics Related To Various Wound Treatment Therapies
- ClinicalTrials.gov ID
- NCT00605189
- Acronym / sponsor ID
- VACP2005-009
- Conditions
- Diabetic Foot Ulcers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study no longer met business objectives
- Enrolment
- 50 participants (actual)
- Lead sponsor
- KCI USA, IncIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 30 Jan 2008 (estimated)
- Results
- Posted 12 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, controlled pilot study examining how cellular energetics related to various wound treatment therapies in patients with diabetic foot ulcers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VAC NPWT | Active comparator | Device: Powered Suction Pump (VAC Freedom) |
| Gauze-Based NPWT | Active comparator | Device: Powered Suction Pump |
| Moist Wound Therapy | Active comparator | Device: MWT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type II diabetes
- Subject has a diabetic foot ulcer 5cm squared or greater
- Subject's diabetic foot ulcer is chronic
Key exclusion criteria (3 listed)
- HgbA1c of 12% or greater
- Presence of cellulitis
- Presence of osteomyelitis
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 |
|---|---|---|
| Powered Suction Pump (VAC Freedom)Also: VAC Freedomcontinuous foam based negative pressure wound therapy | Device | VAC NPWT |
| Powered Suction PumpAlso: Gauze-Based Negative Pressure Wound Therapy Devicecontinuous gauze based negative pressure wound therapy | Device | Gauze-Based NPWT |
| MWTmoist wound therapy | Device | Moist Wound Therapy |
Primary outcome
Compare Energy Charge Between Wound Treatment Therapies
Time frame: Day 0, Day 2, Day 7
Energy charge is a calculated ratio of the parameters ATP (µg), ADP (µg), and AMP (µg) which are measured with the same unit. Energy Charge is calculated as follows: Energy Charge = (ATP + (0.5 * ADP)) / (ATP + ADP + AMP) Where, ATP = Adenosine triphosphate, ADP = Adenosine diphosphate, AMP = Adenosine monophosphate
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.
Related trials for Diabetic Foot Ulcers
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Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
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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
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Gayle M Gordillo, MD study director
Ohio State University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powered Suction Pump (VAC Freedom), Powered Suction Pump and MWT in people with Diabetic Foot Ulcers, run by KCI USA, Inc at 2 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 3 inclusion and 3 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.
Where is the study taking place?
The record lists 2 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 12 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?
Compare Energy Charge Between Wound Treatment Therapies (time frame: Day 0, Day 2, Day 7). 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.