Diabetic Foot UlcerNCT01816672
Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner gd 1 and 2 Diabetic Foot Ulcers.
A study testing AutoloGel and Usual and Customary Care in people with Diabetic Foot Ulcer, run by Cytomedix at 1 site in United States.
Trial summary
The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- AutoloGel and Usual and Customary Care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2015
- 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
- Medicare eligible
- ≥18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 Diabetic Foot Ulcer (DFU; see Appendix 9 for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel). Subjects who have heel ulcers may be included if another, eligible wound is the index ulcer
- For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected. There must be at least 4 cm between the index ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
- Debrided ulcer size between 0.5 cm2 and 20 cm2
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- Demonstrated adequate offloading regimen
- Duration ≥ 1 month at first visit (screening period)
- Subject must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
Who cannot join
- Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- Wagner 3, 4, or 5 DFU (see Appendix 9 for Wagner Classification) Page 15 of 58
- Any clinically infected index ulcer that is apparent on Day 0. The presence of infection is defined by ≥ 2 classic findings of inflammation (erythema, warmth, tenderness, pain, or induration) or purulent secretions (Lipsky, 2012, or see Appendix 4)
- Presence of another wound that is concurrently treated and might interfere with index wound
- Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
- Presence of underlying osteomyelitis, or if osteomyelitis is suspected
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- Received systemic corticosteroids or immunosuppressive agents, hyperbaric oxygen therapy (HBOT), electrostimulation, growth factors, or any cell or tissue-derived products for wounds during the 30 days preceding the screening visit; received radiation therapy or chemotherapy within previous 6 months
- Any malignancy other than non-melanoma skin cancer
- Ischemic ulcer defined as an ankle brachial index (ABI; handheld or Arterial Doppler) < 0.8 (note: if ABI is ≥ 1, then an skin perfusion pressure (SPP) or transcutaneous oximetry (TCOM) must be performed or the subject cannot be enrolled), TCOM < 30 mm Hg, or SPP < 30 mm Hg; toe pressure < 45 mm Hg. These measurements may be concurrent with the initial evaluation of the index ulcer or obtained within 90 days of study enrollment if done prior to that concurrence.
- Subject has radiographic evidence consistent with diagnosis of active Charcot foot
- Untreated Charcot foot or DFUs associated with a treated Charcot deformity in which reconstruction or offloading has not taken place
- Ulcer expected to be treated with any advanced therapeutics (e.g., HBOT)
- Ulcer area decreases by ≥ 30% during 2-week screening/run-in period
- Subjects who are cognitively impaired and do not have a healthcare proxy
- Serum albumin of less than 2.5 g/dL
- Plasma Platelet count of less than 100 x 109/L
- Hemoglobin of less than 10.5 g/dL
- Subject has inadequate venous access for repeated blood draw required for AutoloGel Administration
- Subject requires or is anticipated to require interventions directed at improvement of arterial perfusion to affected area.
Trial locations and contacts
1 site in 1 country.
United States1 site
Forest General Hospital
Hattiesburg, Mississippi, 39401
About this study
Official title: A Multi-Center, Prospective, Clinical Trial Comparing the Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner 1 and 2 Diabetic Foot Ulcers
The purpose of this study is to determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care
Read the detailed description
Autologel is a platelet-rich plasma gel used in the treatment of no-healing chronic wounds. Prospective observational studies of the effectiveness of Autologel have demonstrated promising results in regard to the healing of diabetic foot ulcers including severe Wagner grade 3 and 4 ulcers. The aim of the current trial is to compare the efficacy, measured as wound healing in a single-blind (assessor) randomized controlled trial, of usual and customary care with and without Autologel in treating Wagner 1 and 2 diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- AutoloGel, Usual and Customary Care
- Keywords
- Wagner 1, Wagner 2, Non healing diabetic foot wound
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoloGelDevice
Also called Autologel System
Treatment with Autologel and standard of care twice a week for the first two weeks and once a week thereafter
Usual and Customary CareOther
Also called Standard of care clinically indicated
Standard of care treatment twice weekly for 2 weeks then weekly
| Study group | Role | What they receive |
|---|---|---|
| AutoloGel | Active comparator | AutoloGel treatment Receives: Device: AutoloGel |
| Usual and Customary Care | Other | Standard of care Receives: Other: Usual and Customary Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare time to heal in Wagner 1 and 2 diabetic foot ulcers at 12 weeks treated with AutoloGel versus usual and customary care
Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at consecutive study visits 2 weeks apart. Initial diagnosis of healing by unblinding Principal Investigator will be confirmed by an independent blinded observer using digital photography, planimetry data and wound measurements
Measured: 12 weeks
Secondary outcomes (2)
Assess wound healing trajectory and change in Chronic Wound quality of Life W-QOL scores: and to assess the comparative safety of AutoloGel and usual and customary care
QOL tool administered prior to and at the end of treatment to document the impact of the wound on the subject's life and whether treatment interventions helped a return to improved functioning.
Measured: 13 weeks
Number of patients with adverse events as a measure of tolerability
Frequency and severity of adverse events
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytomedix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816672
- Sponsor's protocol ID
- CM001
- Status last verified
- Oct 2016
- First submitted
- 20 Mar 2013
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective, Clinical Trial Comparing the Efficacy of AutoloGel Therapy to Usual and Customary Care in Wagner 1 and 2 Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT01816672
- Acronym / sponsor ID
- CM001
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Wagner 1, Wagner 2, Non healing diabetic foot wound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- CytomedixIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Mar 2013 (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 determine if AutoloGel platelet rich plasma used on non healing diabetic foot ulcers Wagner gd. 1 and 2 is more effective then the usual and customary care
Detailed description
Autologel is a platelet-rich plasma gel used in the treatment of no-healing chronic wounds. Prospective observational studies of the effectiveness of Autologel have demonstrated promising results in regard to the healing of diabetic foot ulcers including severe Wagner grade 3 and 4 ulcers. The aim of the current trial is to compare the efficacy, measured as wound healing in a single-blind (assessor) randomized controlled trial, of usual and customary care with and without Autologel in treating Wagner 1 and 2 diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AutoloGel | Active comparator | Device: AutoloGelAutoloGel treatment |
| Usual and Customary Care | Other | Other: Usual and Customary CareStandard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Medicare eligible
- ≥18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- The largest non-healing wound, if multiple wounds are present, or the single wound to be treated (index ulcer) is a Wagner 1 or 2 Diabetic Foot Ulcer (DFU; see Appendix 9 for Wagner Classification) that is located on the plantar, medial, or lateral aspect of the foot (including all toe surfaces but not on the heel). Subjects who have heel ulcers may be included if another, eligible wound is the index ulcer
- For subjects with potentially multiple eligible DFUs, the largest ulcer will be selected. There must be at least 4 cm between the index ulcer and other ulcers; if all ulcers are closer than 4 cm, the subject should not be enrolled (screen failure)
Key exclusion criteria (19 listed)
- Subjects known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- Wagner 3, 4, or 5 DFU (see Appendix 9 for Wagner Classification) Page 15 of 58
- Any clinically infected index ulcer that is apparent on Day 0. The presence of infection is defined by ≥ 2 classic findings of inflammation (erythema, warmth, tenderness, pain, or induration) or purulent secretions (Lipsky, 2012, or see Appendix 4)
- Presence of another wound that is concurrently treated and might interfere with index wound
- Ulcer not of DFU pathophysiology (e.g., venous, vasculitic, radiation, rheumatoid, collagen vascular disease, pressure, or arterial etiology)
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 |
|---|---|---|
| AutoloGelAlso: Autologel SystemTreatment with Autologel and standard of care twice a week for the first two weeks and once a week thereafter | Device | AutoloGel |
| Usual and Customary CareAlso: Standard of care clinically indicatedStandard of care treatment twice weekly for 2 weeks then weekly | Other | Usual and Customary Care |
Primary outcome
Compare time to heal in Wagner 1 and 2 diabetic foot ulcers at 12 weeks treated with AutoloGel versus usual and customary care
Time frame: 12 weeks
Complete wound closure is defined as skin re-epithelialization without drainage or dressing requirements confirmed at consecutive study visits 2 weeks apart. Initial diagnosis of healing by unblinding Principal Investigator will be confirmed by an independent blinded observer using digital photography, planimetry data and wound measurements
2 secondary outcomes
Assess wound healing trajectory and change in Chronic Wound quality of Life W-QOL scores: and to assess the comparative safety of AutoloGel and usual and customary care
Time frame: 13 weeks
Number of patients with adverse events as a measure of tolerability
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AutoloGel and Usual and Customary Care in people with Diabetic Foot Ulcer, run by Cytomedix 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 9 inclusion and 19 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 21 Oct 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?
The study was stopped early (reason given: Low enrollment). 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.
What does the primary outcome measure?
Compare time to heal in Wagner 1 and 2 diabetic foot ulcers at 12 weeks treated with AutoloGel versus usual and customary care (time frame: 12 weeks). 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 21 Oct 2016.