Impaired Wound HealingPhase 4NCT02248077
A Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
A Phase 4 study testing AutoloGel and Usual and Customary Care (UCC) in people with Impaired Wound Healing, run by Cytomedix.
Trial summary
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Wound Healing
- What is being tested?
- AutoloGel and Usual and Customary Care (UCC)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2014to Oct 2016
- Phase
- Phase 4
- 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
- For DFU indication:
- Medicare beneficiary
- Males or females ≥ 18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- The single wound to be applied Study Treatment (Index Ulcer) is a Wagner 1-4 DFU (see Section 17.12 Appendix 12 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot (including all toe surfaces and the heel)
- Patients have been treated with UCC at the center for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
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- For patients with multiple potential Index 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 patient should not be enrolled (screen failure)
- Demonstrated offloading regimen
- A wound age of ≥ 30 days at the Screening Visit
- Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician.
- Patient must sign an Informed Consent Form prior to any study-related procedures.
- For VLU indication:
- Medicare beneficiary
- Males or females ≥ 18 years of age
- Diagnosed venous disease
- Patients have been seen at the center/site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- The non-healing wound is located between the knee and ankle and may include ankle
- For patients with multiple potential Index VLUs, 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 patient should not be enrolled (screen failure)
- Demonstrated compression regimen
- A wound age of ≥ 30 days at the Screening visit
- Patient must be willing to comply with the protocol, which will be assessed by enrolling clinician
- Patient must sign an Informed Consent prior to any study-related procedures.
- For PU indication:
- Medicare beneficiary
- Males or females ≥ 18 years of age
- Ulcer of pressure/shear etiology (Stage II, III, IV, see Section 17.13 Appendix 13 for stage definitions)
- Patients have been seen at the site for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
- The single wound to be applied Study Treatment (Index Ulcer) that is located on the heel, ischium, sacrum, coccyx or trochanter
- For patients with multiple potential PUs, 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 patient should not be enrolled (screen failure)
- Demonstrated pressure relief regimen
- A wound age of ≥ 30 days at Screening visit
- Patient must be willing to comply with the Protocol, which will be assessed by enrolling clinician.
- Patient must sign an Informed Consent prior to any study-related procedures.
Who cannot join
- Patients known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- Presence of another wound that is concurrently treated and might interfere with the treatment of the Index wound
- Malignancy in wound bed
- Active clinical wound infection.
- Patient has inadequate venous access for repeated blood draw required for AutoloGel processing
- Patients who are cognitively impaired and do not have a healthcare proxy
About this study
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
- Conditions
- Impaired Wound Healing
- Being tested
- AutoloGel, Usual and Customary Care (UCC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AutoloGelDevice
Usual and Customary Care (UCC)Other
| Study group | Role | What they receive |
|---|---|---|
| AutoloGel | Active comparator | AutoloGel consists of platelet-rich plasma (PRP) gel produced from the patient's own peripheral blood and pharmaceutical additives including calcium chloride, thrombin and ascorbic acid. The AutoloGel product is obtained by processing the patient's own blood using the AutoloGel System. After the final AutoloGel formulation is produced it is used immediately for patient's specific ulcer care. Receives: Device: AutoloGel |
| Usual and Customary Care (UCC) | Other | Standard of care Receives: Other: Usual and Customary Care (UCC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Ulcer Closure
Proportion of patients with complete ulcer closure
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 posted25 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016 (estimated)
Why it stopped: Study was redesigned in collaboration with CMS before it started.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impaired Wound HealingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytomedix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02248077
- Sponsor's protocol ID
- CM-567
- Status last verified
- Oct 2016
- First submitted
- 22 Sep 2014
- 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 Prospective, Randomized, Controlled, Multi-Center, Study Evaluating AutoloGel Therapy for Complete Closure of Wagner Grade 1-4 Diabetic Foot Ulcers, Venous Leg Ulcers and Stage II-IV Pressure Ulcers
- ClinicalTrials.gov ID
- NCT02248077
- Acronym / sponsor ID
- CM-567
- Conditions
- Impaired Wound Healing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was redesigned in collaboration with CMS before it started.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CytomedixIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (estimated)
- First posted
- 25 Sep 2014 (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.
This study is designed to demonstrate the outcome of complete ulcer closure of patients with Wagner Grade 1-4 DFUs, VLUs or Stage II-IV PUs using AutoloGel versus Usual and Customary Care (UCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AutoloGel | Active comparator | Device: AutoloGelAutoloGel consists of platelet-rich plasma (PRP) gel produced from the patient's own peripheral blood and pharmaceutical additives including calcium chloride, thrombin and ascorbic acid. The AutoloGel product is obtained by processing the patient's own blood using the AutoloGel System. After the final AutoloGel formulation is produced it is used immediately for patient's specific ulcer care. |
| Usual and Customary Care (UCC) | Other | Other: Usual and Customary Care (UCC)Standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (33 listed)
- Medicare beneficiary
- Males or females ≥ 18 years of age
- Type I or II diabetes requiring medical treatment as determined by the physician
- The single wound to be applied Study Treatment (Index Ulcer) is a Wagner 1-4 DFU (see Section 17.12 Appendix 12 for Wagner Classification) that is located on the dorsal, plantar, medial, or lateral aspect of the foot (including all toe surfaces and the heel)
- Patients have been treated with UCC at the center for 2 weeks prior to randomization with no greater than 20% reduction in wound area or volume and documented wound measurements are available
Key exclusion criteria (6 listed)
- Patients known to be sensitive to AutoloGel components (calcium chloride, thrombin, ascorbic acid) and/or materials of bovine origin
- Presence of another wound that is concurrently treated and might interfere with the treatment of the Index wound
- Malignancy in wound bed
- Active clinical wound infection.
- Patient has inadequate venous access for repeated blood draw required for AutoloGel processing
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 |
|---|---|---|
| AutoloGel | Device | AutoloGel |
| Usual and Customary Care (UCC) | Other | Usual and Customary Care (UCC) |
Primary outcome
Complete Ulcer Closure
Time frame: 12 weeks
Proportion of patients with complete ulcer closure
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 21 Oct 2016.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing AutoloGel and Usual and Customary Care (UCC) in people with Impaired Wound Healing, run by Cytomedix.
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 33 inclusion and 6 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 21 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Ulcer Closure (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.