DiabetesNCT00215735
Effect of Platelet Concentrate in Treatment of Diabetic Ulcers
A study testing debridement, dressing, and APC in people with Diabetes, run by Harvest Technologies at 9 sites in United States.
Trial summary
Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- debridement, dressing, and APC
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 9 sitesUnited States
- Study dates
- Jun 2004to Sep 2005
- Phase
- Interventional
- 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
None listed.
Who cannot join
- -
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Blair Medical Associates
Altoona, Pennsylvania, 16602
New England Medical Center Hospital
Boston, Massachusetts, 02111
Washington Regional Medical Center
Fayetteville, Alaska, 72703
Tennessee Christian Hospital
Madison, Tennessee, 37115
St. Luke's Medical Ctr
Milwaukee, Wisconsin, 53215
Lucerne Hospital
Orlando, Florida, 32806
Roger Williams Hospital
Providence, Rhode Island, 02908
Traveling Medical Services
Southfield, Michigan, 48075
Bay Pines V.A. Medical Center
St. Petersburg, Florida, 33708
About this study
Official title: Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers
Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds
Read the detailed description
The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.
- Conditions
- Diabetes
- Being tested
- debridement, dressing, and APC
- Keywords
- diabetes, Ulcer, APC
- Medical subject headings
- Diabetes Mellitus, Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
debridement, dressing, and APCDevice
ebridement, dressing, and APC
| Study group | Role | What they receive |
|---|---|---|
| APC Treatment | Experimental | wound debridement and treatment with APC Receives: Device: debridement, dressing, and APC |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJun 2004
- Primary completionSep 2005
- Study completionSep 2005
Why it stopped: inconclusive results, market feasiblity
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Harvest Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Iafrati, MD, Principal investigator, Tufts Medical Ctr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00215735
- Sponsor's protocol ID
- 2003-1
- Status last verified
- Mar 2012
- First submitted
- 14 Sep 2005
- Last updated
- 20 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Effectiveness of Harvest Autologous Platelet Concentrate and Autologous Thrombin for Treatment of Lower Extremity Chronic Diabetic Ulcers
- ClinicalTrials.gov ID
- NCT00215735
- Acronym / sponsor ID
- 2003-1
- Conditions
- Diabetes
- Keywords
- diabetes, Ulcer, APC
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inconclusive results, market feasiblity
- Lead sponsor
- Harvest TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 22 Sep 2005 (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.
Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds
Detailed description
The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.
Study design
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| APC Treatment | Experimental | Device: debridement, dressing, and APCwound debridement and treatment with APC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| debridement, dressing, and APCebridement, dressing, and APC | Device | APC Treatment |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: inconclusive results, market feasiblity). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2012.
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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.
Mark Iafrati, MD principal investigator
Tufts Medical Ctr
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing debridement, dressing, and APC in people with Diabetes, run by Harvest Technologies at 9 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 0 inclusion and 1 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 20 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
The study was stopped early (reason given: inconclusive results, market feasiblity). Results are not available in the source record.
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.
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 20 Mar 2012.