Venous UlcerPhase 3NCT00273234
Clinical Effectiveness of Topical Autologous Platelet Gel for the Treatment of Venous Ulcers
A Phase 3 study testing Autologous Platelet Gel (APG) in people with Venous Ulcer, run by National Healing Corporation at 6 sites in United States.
Trial summary
The purpose of this study is to compare the effectiveness of standard venous ulcer care to standard venous ulcer care plus a cell based product made from the patients own blood. This product, Autologous Platelet Concentrate (APC), is a concentrate of cells in the bloodstream called platelets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Ulcer
- What is being tested?
- Autologous Platelet Gel (APG)
- Type of treatment
- Surgery or procedure
- How many people
- 70 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2006to Nov 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Presence of venous insufficiency lower extremity (below knee) ulcer
- 4 weeks
- Area of ulcer is 1 cm2 - 20 cm2
- Subject is receiving standard wound care
- ABI ≥ 0.8 or, if diabetic, TBI ≥ 0.8 on the study limb.
- Subject has adequate venous access for phlebotomy.
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- Subject has access to reliable outpatient dressing care (self, family member, nursing staff, etc.)
- Hematocrit is > 30%
- Platelet Count is > 100,000
- INR < 1.3
- Subject has no known coagulopathies
- Serum Albumin > 2.5
- If diabetic, HgbA1C < 10%
- Venous reflux < 20 seconds by ultrasonography
Who cannot join
- Presence of arterial insufficiency (ABI or if diabetic TBI <0.8)
- Subject has received biological therapy within 30 days of enrollment
- Subject is receiving radiation therapy near the ulcer
- Active infection of the study wound, or osteomyelitis, or cellulitis has been diagnosed. The patient may be enrolled only after the infection has been controlled, including:
- Debridement if necessary
- Patient has received at least 2 weeks of appropriate antibiotics
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- Allergy to bovine thrombin
- Alcohol or drug abuse within 6 months of enrollment
- Subject has been diagnosed with AIDS, HIV, or Hepatitis
- Subject is taking immunosuppressive therapy
- Subject is taking pentoxyfilline (Trental®)
- Steroid use within 7 days of enrollment
- Presence of a non-study ulcer within 2.0cm of the study ulcer
- Angioplasty by bypass or endovascular therapy within 4 weeks of enrollment
- Suspected sleep apnea
- Active Cancer
- BMI > 40 kg/m2
- Severe Rheumatoid Arthritis
- Collagen vascular disease
- Female who is pregnant or lactating or not using a reliable birth control method if of child-bearing age
- Wound bed with exposed bone, tendon, or fascia
- Renal insufficiency defined as Creatinine > 3 mg/dL
- Hepatic insufficiency defined as total Bilirubin > 2 mg/dL
- Enrollment, within the past 3 months, in any study related to wound healing
- Closure of study wound ≥ 40% within 2 screening visits of enrollment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ohio State University East Wound Healing Center
Columbus, Ohio, 43205
Anna Jacques Hospital Wound Healing Center
Newburyport, Massachusetts, 01950
Johnston Therapeutic Wound Clinic
Smithfield, North Carolina, 27577
Palms of Pasadena Wound Healing Center
St. Petersburg, Florida, 33707
Parrish Wound Healing Clinic
Titusville, Florida, 32796
East Texas Medical Center Wound Healing Center
Tyler, Texas, 75701
About this study
Official title: Clinical Evaluation of the Safety and Effectiveness of Topical Autologous Platelet Gel (APG) for the Treatment of Lower Extremity Chronic Venous Insufficiency Ulcers. A Multicenter, Randomized, Controlled Clinical Trial
The purpose of this study is to compare the effectiveness of standard venous ulcer care to standard venous ulcer care plus a cell based product made from the patients own blood. This product, Autologous Platelet Concentrate (APC), is a concentrate of cells in the bloodstream called platelets.
Read the detailed description
The purpose of this Pilot clinical study is to make a preliminary clinical and procedural assessment of the treatment of chronic venous stasis ulcers with Autologous Platelet Gel. The information and knowledge gained in the Pilot Study will be used to refine the Investigational Plan under which a Pivotal Clinical Study will be conducted. One of the advantages of conducting a pilot study is that it might give advance warning about where the main research project could fail, where research protocols may not or cannot be followed, or whether proposed methods or instruments are inappropriate or too complicated to achieve the expected clinical outcomes. The Pilot Study will provide preliminary data with which to:
- Assess the feasibility of a (full-scale) study/survey
- Refine the clinical protocol procedures
- Assess the likely success of proposed recruitment approaches
- Identifying logistical problems which might occur using proposed methods
- Estimating variability in outcomes to help determine sample size
- Determine what resources (finance, staff) are needed for a planned study
- Assess the proposed data collection and analysis techniques to uncover potential problems
- Confirm the study objectives are feasible
- Train researcher in the elements of the research process and protocol
- Assess the magnitude of the difference in the effectiveness of the investigational treatment vs control treatment
The pilot study will provide supporting clinical data for an IDE application to FDA for approval to conduct a Pivotal Study of the safety and effectiveness of APG for the treatment of chronic venous stasis ulcers. The study will evaluate the hypothesis that treatment of a chronic venous ulcer with APG prepared from Autologous Platelet Concentrate (APC+) (and the associated autologous growth factors) and Topical Thrombin (TT) has the potential to accelerate the re-epithelialization process. Harvest Technologies will submit a marketing application to FDA to expand the labeling of the SmartPReP2® Platelet Concentrate System, including its accessory kits, with the specific indication to produce APC for the purpose of promoting healing of chronic venous ulcers of the lower extremity.
60 to 100 study subjects will be enrolled from six investigational sites in this single-phase clinical trial.
The SmartPReP®2 Platelet Concentrate System is a dedicated microprocessor-controlled centrifuge. The SmartPReP®2 centrifuge and its accessory, the APC+ Process Kit, are currently available and used to produce Autologous Platelet Concentrate. The Harvest SmartJet Dual Applicator Kit is legally marketed to apply autologous blood products (K000456, K011032, and K020252). Topical Thrombin (TT), (bovine origin), USP is an approved pharmaceutical (NDC 52604-7102-1) marketed by Jones Pharma, Inc. (Thrombin-JMI®) that is not supplied by Harvest and must be obtained by the practitioner.
This study will compare standard of care medical therapy with and without APC+ and TT. Therefore, the study ulcers of the Investigational Group will receive treatment with APC+ and TT as an adjunctive treatment modality in addition to standard therapy.
- Conditions
- Venous Ulcer
- Being tested
- Autologous Platelet Gel (APG)
- Keywords
- Venous, Ulcer, autologous, platelet, healing
- Medical subject headings
- Varicose Ulcer, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Platelet Gel (APG)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Healing
Secondary outcomes (2)
Percent Healing per unit of time (speed)
Pain reduction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2006 (estimated)
- Study startJan 2006
- Study completionNov 2006
Why it stopped: Lack of financial support. Study criteria severly limited enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous UlcerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- National Healing Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bob Bartlett, MD, Principal investigator, National Healing CorporationSteve Martin, PhD Candidate, Health Science, Principal investigator, Touro University International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00273234
- Sponsor's protocol ID
- NHC-2006-01
- Status last verified
- Mar 2007
- First submitted
- 4 Jan 2006
- Last updated
- 6 Mar 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Effectiveness of Topical Autologous Platelet Gel (APG) for the Treatment of Lower Extremity Chronic Venous Insufficiency Ulcers. A Multicenter, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00273234
- Acronym / sponsor ID
- NHC-2006-01
- Conditions
- Venous Ulcer
- Keywords
- Venous, Ulcer, autologous, platelet, healing
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of financial support. Study criteria severly limited enrollment.
- Enrolment
- 70 participants
- Lead sponsor
- National Healing CorporationIndustry (pharma, biotech, devices)
- Study start
- Jan 2006
- Study completion
- Nov 2006
- First posted
- 9 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the effectiveness of standard venous ulcer care to standard venous ulcer care plus a cell based product made from the patients own blood. This product, Autologous Platelet Concentrate (APC), is a concentrate of cells in the bloodstream called platelets.
Detailed description
The purpose of this Pilot clinical study is to make a preliminary clinical and procedural assessment of the treatment of chronic venous stasis ulcers with Autologous Platelet Gel. The information and knowledge gained in the Pilot Study will be used to refine the Investigational Plan under which a Pivotal Clinical Study will be conducted. One of the advantages of conducting a pilot study is that it might give advance warning about where the main research project could fail, where research protocols may not or cannot be followed, or whether proposed methods or instruments are inappropriate or too complicated to achieve the expected clinical outcomes. The Pilot Study will provide preliminary data with which to:
- Assess the feasibility of a (full-scale) study/survey
- Refine the clinical protocol procedures
- Assess the likely success of proposed recruitment approaches
- Identifying logistical problems which might occur using proposed methods
- Estimating variability in outcomes to help determine sample size
- Determine what resources (finance, staff) are needed for a planned study
- Assess the proposed data collection and analysis techniques to uncover potential problems
- Confirm the study objectives are feasible
- Train researcher in the elements of the research process and protocol
- Assess the magnitude of the difference in the effectiveness of the investigational treatment vs control treatment
The pilot study will provide supporting clinical data for an IDE application to FDA for approval to conduct a Pivotal Study of the safety and effectiveness of APG for the treatment of chronic venous stasis ulcers. The study will evaluate the hypothesis that treatment of a chronic venous ulcer with APG prepared from Autologous Platelet Concentrate (APC+) (and the associated autologous growth factors) and Topical Thrombin (TT) has the potential to accelerate the re-epithelialization process. Harvest Technologies will submit a marketing application to FDA to expand the labeling of the SmartPReP2® Platelet Concentrate System, including its accessory kits, with the specific indication to produce APC for the purpose of promoting healing of chronic venous ulcers of the lower extremity.
60 to 100 study subjects will be enrolled from six investigational sites in this single-phase clinical trial.
The SmartPReP®2 Platelet Concentrate System is a dedicated microprocessor-controlled centrifuge. The SmartPReP®2 centrifuge and its accessory, the APC+ Process Kit, are currently available and used to produce Autologous Platelet Concentrate. The Harvest SmartJet Dual Applicator Kit is legally marketed to apply autologous blood products (K000456, K011032, and K020252). Topical Thrombin (TT), (bovine origin), USP is an approved pharmaceutical (NDC 52604-7102-1) marketed by Jones Pharma, Inc. (Thrombin-JMI®) that is not supplied by Harvest and must be obtained by the practitioner.
This study will compare standard of care medical therapy with and without APC+ and TT. Therefore, the study ulcers of the Investigational Group will receive treatment with APC+ and TT as an adjunctive treatment modality in addition to standard therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Presence of venous insufficiency lower extremity (below knee) ulcer
- Area of ulcer is 1 cm2 - 20 cm2
- Subject is receiving standard wound care
- ABI ≥ 0.8 or, if diabetic, TBI ≥ 0.8 on the study limb.
- Subject has adequate venous access for phlebotomy.
Key exclusion criteria (25 listed)
- Presence of arterial insufficiency (ABI or if diabetic TBI <0.8)
- Subject has received biological therapy within 30 days of enrollment
- Subject is receiving radiation therapy near the ulcer
- Active infection of the study wound, or osteomyelitis, or cellulitis has been diagnosed. The patient may be enrolled only after the infection has been controlled, including:
- Debridement if necessary
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 |
|---|---|---|
| Autologous Platelet Gel (APG) | Procedure or surgery | – |
Primary outcome
Complete Healing
2 secondary outcomes
Percent Healing per unit of time (speed)
Pain reduction
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2007.
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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.
Bob Bartlett, MD principal investigator
National Healing Corporation
Steve Martin, PhD Candidate, Health Science principal investigator
Touro University International
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Autologous Platelet Gel (APG) in people with Venous Ulcer, run by National Healing Corporation 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 14 inclusion and 25 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: withdrawn, as of the sponsor's last update on 6 Mar 2007. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Complete Healing. 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 6 Mar 2007.