Diabetic Foot UlcersNCT00761176
A Pilot Study of the Provant Therapy System in Subjects With Diabetic Foot Ulcers
A study testing The Provant Therapy System in people with Diabetic Foot Ulcers, run by Regenesis Biomedical, Inc. at 1 site in United States.
Trial summary
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Foot Ulcers
- What is being tested?
- The Provant Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Mar 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females > 18 years of age
- History of Type 1 or 2 Diabetes Mellitus
- A diabetic plantar foot wound, Wagner grade 1 or 2 (See Exclusion Criteria, number four (4).
- The qualifying wound must have been present for ≥ 30 days; (the age of the wound will be recorded) based on patient history or documentation in the medical record.
- Ankle Brachial Index (ABI) score ≥ 0.7 and ≤ 1.2 with present palpable posterior tibial pulse or dorsalis pedis pulse in index foot
- Wound surface area ≥ 1.0 cm2 and ≤ 16.0 cm2
- Female subjects of childbearing age will be expected to test negative after taking a serum pregnancy test. Additionally, they must be willing to use an adequate and reliable method of contraception for the study duration. Females who are postmenopausal must have been postmenopausal at least one year or twelve months.
Who cannot join
- Glycosylated Hemoglobin (HbA1c) greater than 12 within 30 days of enrollment
- Absent pedal Doppler signals in the foot with the index wound or the presence of significant peripheral artery disease ,
- Concurrent treatment of the index wound with another advanced wound care device (i.e. negative pressure wound therapy, non-contact ultrasound, hyperbaric oxygen, electrical stimulation) or pharmaceutical (e.g. growth factors) within thirty (30) days of enrollment.
- Index wounds with exposed muscle, ligament or tendon, or which probe to bone regardless of classification-See Inclusion Criteria no. two ( 2).
- Wounds due to a nondiabetic etiology (e.g. venous stasis, arterial insufficiency, etc.)
- Cellulitis, osteomyelitis, or other clinical evidence of infection involving the index wound.
Show all 13Show fewer
- History of malignancy
- Concurrent use of high dose immunosuppressant or cytotoxic drugs
- Implanted pacemaker or defibrillator
- Metallic implant involving the index foot or ankle
- Implanted system with a metallic lead
- Pregnant or lactating females
- Concurrent participation in another clinical trial. 14) An unwillingness of the patient to comply with the study procedures and the required follow-up regimen.
Trial locations and contacts
1 site in 1 country.
United States1 site
Winston - Salem Outpatient Clinic
Winston-Salem, North Carolina, 27103
About this study
Official title: A Controlled Study Comparing Basic Wound Care to the Provant® Therapy System as an Adjunct to Basic Wound Care for Wound Surface Area Reduction in Diabetic Plantar Foot Wounds
The objective of this study is to compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone.
Read the detailed description
According to the American Diabetes Association (ADA), there are approximately 20.8 million people in the US with diabetes or 7% of the population (1). A significant number of the diabetic population is prone to pedal ulceration and estimates reveal that 15-20% of this population will develop a foot ulcer in their lifetime.
Treatment of diabetic foot ulcerations have posed a problem to healthcare providers for many years. The literature describes many different modalities for direct wound treatment strategies. Most of these treatments rely on the timely application of biological dressings, offloading of the wound, regular (and often inconvenient) visits to the doctor, and most important, compliance by the patient. It is not uncommon for such wounds to be present for greater than six months, despite use of debridement, off-loading and other basic wound care techniques, before presenting for advanced therapy.
Provant has been selected for study because:
- It is already indicated for the adjunctive palliative treatment of postoperative pain and edema in superficial soft tissue.
- It is a non-invasive wound treatment system which utilizes a proprietary PRFE signal which is hypothesized to trigger the release of endogenous growth factors that induce mitosis through accelerating the cell cycle, using a Ca+2 mediated pathway. The result is a significant increase in the rate of cell replication.
- It has also been shown that PRFE triggers a genetic sequence or cascade of 'wound repair' genes critical for the four stages of wound healing: inflammation, granulation, epithelialization, and remodeling.
- It has been utilized in the VA Health System since 2004 with no serious adverse events attributable to the device.
This study will assess as an endpoints:
- Primary - the incidence of wounds reaching complete closure, and
- Secondary - the time to complete wound closure percentage reduction in wound area, percentage reduction in wound volume, and rate of healing mm2/day and mm3/day.
- Conditions
- Diabetic Foot Ulcers
- Being tested
- The Provant Therapy System
- Keywords
- Diabetes, Ulcers, Wounds
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Provant Therapy SystemDevice
Also called Radio frequency generator devices
The Provant Wound Therapy System is a safe adjuvant non-invasive medical device.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | No intervention | Standard of Care will be utilized without the device. |
| The Provant Therapy System | Other | Thirty minutes, twice daily treatment Receives: Device: The Provant Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Incidence of Wounds Reaching Complete Closure
Measured: approximate one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Protocol Violations noted for 6 of 8 patients
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regenesis Biomedical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mike Wilson, DPM, Principal investigator, Winston - Salem Outpatient Clinic, WG Hefner VAMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00761176
- Sponsor's protocol ID
- RGI-08-08-1
- Status last verified
- Nov 2015
- First submitted
- 25 Sep 2008
- Last updated
- 5 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Study Comparing Basic Wound Care to the Provant® Therapy System as an Adjunct to Basic Wound Care for Wound Surface Area Reduction in Diabetic Plantar Foot Wounds
- ClinicalTrials.gov ID
- NCT00761176
- Acronym / sponsor ID
- RGI-08-08-1
- Conditions
- Diabetic Foot Ulcers
- Keywords
- Diabetes, Ulcers, Wounds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Protocol Violations noted for 6 of 8 patients
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Regenesis Biomedical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 29 Sep 2008 (estimated)
- Results
- Posted 5 Jan 2016
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 compare the reduction in wound surface areas between patients with diabetic ulcers utilizing Provant's pulsed radio frequency energy therapy (PRFE) as an adjunct to standardized basic wound care to those utilizing standardized basic wound care alone.
Detailed description
According to the American Diabetes Association (ADA), there are approximately 20.8 million people in the US with diabetes or 7% of the population (1). A significant number of the diabetic population is prone to pedal ulceration and estimates reveal that 15-20% of this population will develop a foot ulcer in their lifetime.
Treatment of diabetic foot ulcerations have posed a problem to healthcare providers for many years. The literature describes many different modalities for direct wound treatment strategies. Most of these treatments rely on the timely application of biological dressings, offloading of the wound, regular (and often inconvenient) visits to the doctor, and most important, compliance by the patient. It is not uncommon for such wounds to be present for greater than six months, despite use of debridement, off-loading and other basic wound care techniques, before presenting for advanced therapy.
Provant has been selected for study because:
- It is already indicated for the adjunctive palliative treatment of postoperative pain and edema in superficial soft tissue.
- It is a non-invasive wound treatment system which utilizes a proprietary PRFE signal which is hypothesized to trigger the release of endogenous growth factors that induce mitosis through accelerating the cell cycle, using a Ca+2 mediated pathway. The result is a significant increase in the rate of cell replication.
- It has also been shown that PRFE triggers a genetic sequence or cascade of 'wound repair' genes critical for the four stages of wound healing: inflammation, granulation, epithelialization, and remodeling.
- It has been utilized in the VA Health System since 2004 with no serious adverse events attributable to the device.
This study will assess as an endpoints:
- Primary - the incidence of wounds reaching complete closure, and
- Secondary - the time to complete wound closure percentage reduction in wound area, percentage reduction in wound volume, and rate of healing mm2/day and mm3/day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | No intervention | –Standard of Care will be utilized without the device. |
| The Provant Therapy System | Other | Device: The Provant Therapy SystemThirty minutes, twice daily treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males and females > 18 years of age
- History of Type 1 or 2 Diabetes Mellitus
- A diabetic plantar foot wound, Wagner grade 1 or 2 (See Exclusion Criteria, number four (4).
- The qualifying wound must have been present for ≥ 30 days; (the age of the wound will be recorded) based on patient history or documentation in the medical record.
- Ankle Brachial Index (ABI) score ≥ 0.7 and ≤ 1.2 with present palpable posterior tibial pulse or dorsalis pedis pulse in index foot
Key exclusion criteria (13 listed)
- Glycosylated Hemoglobin (HbA1c) greater than 12 within 30 days of enrollment
- Absent pedal Doppler signals in the foot with the index wound or the presence of significant peripheral artery disease ,
- Concurrent treatment of the index wound with another advanced wound care device (i.e. negative pressure wound therapy, non-contact ultrasound, hyperbaric oxygen, electrical stimulation) or pharmaceutical (e.g. growth factors) within thirty (30) days of enrollment.
- Index wounds with exposed muscle, ligament or tendon, or which probe to bone regardless of classification-See Inclusion Criteria no. two ( 2).
- Wounds due to a nondiabetic etiology (e.g. venous stasis, arterial insufficiency, etc.)
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 |
|---|---|---|
| The Provant Therapy SystemAlso: Radio frequency generator devicesThe Provant Wound Therapy System is a safe adjuvant non-invasive medical device. | Device | The Provant Therapy System |
Primary outcome
The Incidence of Wounds Reaching Complete Closure
Time frame: approximate one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- 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
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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.
Mike Wilson, DPM principal investigator
Winston - Salem Outpatient Clinic, WG Hefner VAMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Provant Therapy System in people with Diabetic Foot Ulcers, run by Regenesis Biomedical, Inc. at 1 site 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 7 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: stopped early, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 5 Jan 2016). 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?
The Incidence of Wounds Reaching Complete Closure (time frame: approximate one year). 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 5 Jan 2016.