Impaired Wound HealingCellutomeNCT02148302
Clinical Trial to Evaluate Blister Graft Utilizing a Novel Harvesting Device for Treatment of Venous Leg Ulcers
A study testing Harvesting Device (CelluTome©) in people with Impaired Wound Healing and Venous Insufficiency of Leg, run by SerenaGroup, Inc. at 18 sites in United States.
Trial summary
Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study is intended to establish the superior effectiveness of epidermal grafting and multi-layer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Impaired Wound Healing, Venous Insufficiency of Leg, Diabetic Ulcers
- What is being tested?
- Harvesting Device (CelluTome©)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 18 sitesUnited States
- Study dates
- May 2014to Nov 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old.
- Adequate arterial flow (Ankle Brachial Pressure Index (ABI) > 0.75. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms), OR Skin Perfusion Pressure (SPP) >30, OR biphasic PVR OR TBI > 0.60 OR TCPO2 > 30mmHg OR adequate perfusion as demonstrated on florescent angiography, LUNA®).
- Presence of a venous leg ulcer through full skin thickness but not down to muscle, tendon or bone. The largest ulcer will be the index ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart from the index ulcer.
- Study ulcer has been present for at least one month prior to the initial screening visit, and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration.
- Study ulcer is a minimum of 2.0 cm2 / maximum of 25 cm2 at the randomization visit.
- The target ulcer has been treated with compression therapy for at least 14 days prior to randomization.
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- Ulcer has a clean, granulating base with minimal adherent slough at the randomization visit.
- Patient understands / is willing to participate in the clinical study and can comply with weekly visits and follow-up regimen.
- Patient has read and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
Who cannot join
- Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
- Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency. These may include, but are not limited to: fungal ulcerations, malignant ulcerations, and ulcerations due to arterial insufficiency.
- Study ulcer exhibits clinical signs and symptoms of infection at the SV (screening visit) or TV1 (Treatment Visit 1).
- Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- Study ulcer is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. The patient may be enrolled after a negative biopsy.
- Patients with a history of more than two weeks treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
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- Study ulcer has been previously treated with tissue engineered materials (e.g. Apligraf® or Dermagraft®) or other scaffold materials (e.g. Oasis, meristem) within the last 30 days
- Study ulcer requiring negative pressure wound therapy or hyperbaric oxygen during the course of the trial.
- Ulcers on the dorsum of the foot or with more than 50% of the ulcer below the malleolus are excluded.
- Pregnant or breast feeding.
- Known history of having Acquired Immunodeficiency Syndrome (AIDS) or with a history of Human Immunodeficiency Virus (HIV).
- Known uncontrolled Diabetes Mellitus, as measured by an HbA1c > 10%.
- Ulcers that have healed more than 40% during the screening phase are excluded.
- Patients on any investigational drug(s) or therapeutic device(s) within 30 days preceding screening (i.e. S1); or patient or physician anticipates use of any of these therapies by the subject during the course of the study.
- History of radiation at ulcer site.
- Presence of one or more medical conditions, including renal, hepatic, hematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study.
- Patients who are unable to understand the aims and objectives of the trial.
- Presence of any condition(s) which seriously compromises the subject's ability to complete this study, or has a known history of poor adherence with medical treatment.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Akron General Medical Center
Akron, Ohio, 44307
St Marys Health Care System
Athens, Georgia, 30606
Eric Lullove, Dpm
Boca Raton, Florida, 33433
Summit Health Hospital
Chambersburg, Pennsylvania, 17201
Bay Area Hospital
Coos Bay, Oregon, 97420
Inspira Health Network
Elmer, New Jersey, 08318
Saint Vincent Health Center
Erie, Pennsylvania, 16544
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Pharmakon Medical Research
Harrisonburg, Virginia, 22801
Advanced Research Institute of Miami
Homestead, Florida, 33030
Michael Miller, Do
Indianapolis, Indiana, 46234
Armstrong County Memorial Hospital
Kittanning, Pennsylvania, 16201
Largo Medical Center
Largo, Florida, 33770
GF Professional Research
Miami Lakes, Florida, 33016
Regional Medical Center
Orangeburg, South Carolina, 29118
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
University of Toledo Medical Center
Toledo, Ohio, 43614
St John Medical Center
Tulsa, Oklahoma, 74135
About this study
Official title: A Multi-center Randomized Open-Label Controlled Clinical Trial Evaluating Suction Blister Grafting Utilizing a Novel Harvesting Device (CelluTome©) and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study is intended to establish the superior effectiveness of epidermal grafting and multi-layer compression over that of multi-layer compression alone, in the treatment of venous leg ulcers.
Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.
Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Epidermal grafting has been a reconstructive option for decades; however, to date there has not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting System permits the harvesting of epidermal blister grafts at the patient's bedside without the need for anesthesia. The grafts can be easily transferred to the wound bed. In case studies, epidermal grafting appeared to be effective in reducing wound size and accelerating closure of venous leg ulcers.
Read the detailed description
This study is a multi-center, randomized, controlled open-label study designed to evaluate the safety and effectiveness of epidermal grafting using the CelluTome® system plus multi-layer compression therapy versus multi-layer compression (SOC) in the treatment of venous leg ulcers.
The study will have two phases: Screening and Treatment. The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility.
At or up to 14 days before the first Screening Phase Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.
At the first Screening Phase Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.
Patients whose target ulcer has been treated with compression therapy for the previous two weeks are eligible to enter the treatment phase once all of the inclusion and exclusion criteria are met. If the ulcer has not received compression, the patient should be placed in compression and enrolled in the study after 14 days of compression therapy. Ulcers that have decreased in size by more than 40% during the screening period will be excluded as "rapid healer." Subjects that meet the inclusion/exclusion criteria at the end of screening will be randomized to either the Cellutome graft plus Standard of Care group or just the Standard of Care group. At Treatment Visit 7, subjects in the Standard of Care group that have healed <40% will be allowed to cross over to the Cellutome graft group.
The study will consist of up to 30 centers in the United States each contributing about 10 subjects per center in order to obtain 194 evaluable subjects. The investigators anticipate a 10% drop out rate during the trial therefore a total of 213 subjects will be recruited. This trial employs an adaptive design therefore the enrollment numbers may be reduced or increased based on planned interim analysis.
- Being tested
- Harvesting Device (CelluTome©)
- Keywords
- Venous Leg Ulcerations, Epidermal Grafts, Chronic wounds, Clinical trial, Protease levels in chronic wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Harvesting Device (CelluTome©)Device
Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.
| Study group | Role | What they receive |
|---|---|---|
| Harvesting Device (CelluTome©) | Experimental | open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers.
Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8.
A run-in period of two weeks followed by twelve weeks of active treatment Receives: Device: Harvesting Device (CelluTome©) |
| Control: SOC alone | No intervention | The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Healed Wounds
Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone
Measured: 12 weeks
Secondary outcomes (3)
Wound Area Change at Week 4
Percentage of wound area change at week 4
Measured: 4 weeks
Wound Area Change at Week 12
Percentage of wound area change at Week 12
Measured: 12 weeks
Incidence of Adverse Event
Incidence of adverse events with epidermal grafting versus standard of care.
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 posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionNov 2017
- Study completionNov 2017
Why it stopped: Stopped by sponsor. No interest in continuing trial due to business changes.
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- SerenaGroup, Inc.
- Sponsor type
- Research network
- Collaborators
- Kinetic Concepts, Inc.
- Responsible party
- Sponsor
- Investigators
- Thomas Serena, MD, Principal investigator, SerenaGroup, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148302
- Sponsor's protocol ID
- CELLUTOME-VLU-013
- Acronym
- Cellutome
- Status last verified
- Apr 2020
- First submitted
- 27 Jan 2014
- Last updated
- 29 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Open-Label Controlled Clinical Trial Evaluating Suction Blister Grafting Utilizing a Novel Harvesting Device (CelluTome©) and Standard of Care vs. Standard of Care Alone in the Treatment of Venous Leg Ulcers
- ClinicalTrials.gov ID
- NCT02148302
- Acronym / sponsor ID
- Cellutome / CELLUTOME-VLU-013
- Keywords
- Venous Leg Ulcerations, Epidermal Grafts, Chronic wounds, Clinical trial, Protease levels in chronic wounds
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Stopped by sponsor. No interest in continuing trial due to business changes.
- Enrolment
- 123 participants (actual)
- Lead sponsor
- SerenaGroup, Inc.Research network
- Collaborators
- Kinetic Concepts, Inc.
- Study start
- May 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Posted 29 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epidermal grafts are believed to promote healing by two mechanisms: graft take and the promotion of wound healing through the delivery of growth factors and the essential elements of tissue repair and wound healing.28 This study is intended to establish the superior effectiveness of epidermal grafting and multi-layer compression over that of multi-layer compression alone, in the treatment of venous leg ulcers.
Millions of Americans are afflicted with painful, open, draining sores on their lower extremities. These sores are referred to as venous leg ulcerations (VLUs). Under the best of circumstances these ulcers require weeks or months to heal. Not uncommonly wound care specialists see patients who have suffered for years or faced amputation of the limb as their only option to alleviate the pain.
Standard of care will result in healing in 50% of venous leg ulcers in 12 weeks. However, roughly half of patients suffering from venous ulcers will require advanced therapy. Epidermal grafting has been a reconstructive option for decades; however, to date there has not been a reliable and reproducible system to harvest epidermis. The CelluTome® Harvesting System permits the harvesting of epidermal blister grafts at the patient's bedside without the need for anesthesia. The grafts can be easily transferred to the wound bed. In case studies, epidermal grafting appeared to be effective in reducing wound size and accelerating closure of venous leg ulcers.
Detailed description
This study is a multi-center, randomized, controlled open-label study designed to evaluate the safety and effectiveness of epidermal grafting using the CelluTome® system plus multi-layer compression therapy versus multi-layer compression (SOC) in the treatment of venous leg ulcers.
The study will have two phases: Screening and Treatment. The Screening Phase (1 -14 days) is designed to determine whether subjects are eligible to proceed to the Treatment Phase of the study and consists of a series of screening assessments designed to determine eligibility.
At or up to 14 days before the first Screening Phase Visit (S1), written informed consent from the subject will be obtained by the Investigator or suitably qualified designee before the performance of any other protocol-specific procedure.
At the first Screening Phase Visit (S1), the Investigator will select the study (target) ulcer. Each subject will have only one VLU selected as the study (target) ulcer. In the situation where a subject has more than one VLU at the S1 visit, the Investigator will select the largest VLU that meets the eligibility criteria of the protocol as the study (target) ulcer.
Patients whose target ulcer has been treated with compression therapy for the previous two weeks are eligible to enter the treatment phase once all of the inclusion and exclusion criteria are met. If the ulcer has not received compression, the patient should be placed in compression and enrolled in the study after 14 days of compression therapy. Ulcers that have decreased in size by more than 40% during the screening period will be excluded as "rapid healer." Subjects that meet the inclusion/exclusion criteria at the end of screening will be randomized to either the Cellutome graft plus Standard of Care group or just the Standard of Care group. At Treatment Visit 7, subjects in the Standard of Care group that have healed <40% will be allowed to cross over to the Cellutome graft group.
The study will consist of up to 30 centers in the United States each contributing about 10 subjects per center in order to obtain 194 evaluable subjects. The investigators anticipate a 10% drop out rate during the trial therefore a total of 213 subjects will be recruited. This trial employs an adaptive design therefore the enrollment numbers may be reduced or increased based on planned interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Harvesting Device (CelluTome©) | Experimental | Device: Harvesting Device (CelluTome©)open-label trial designed to evaluate the safety and effectiveness of Epidermal grafting plus multi-layer compression therapy versus multi-layer compression alone in the healing of venous leg ulcers. Epidermal grafting will be applied up to three times in the treatment arm: at day zero, week 4 and week 8. A run-in period of two weeks followed by twelve weeks of active treatment |
| Control: SOC alone | No intervention | –The Standard of Care therapy in this study is multi-layer compression therapy. A number of compression bandaging systems are commercially available. The trial will utilize Coban-2 (3M, Minneapolis, MN). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least 18 years old.
- Adequate arterial flow (Ankle Brachial Pressure Index (ABI) > 0.75. (Calculations will be made using measurements from both posterior tibial and dorsalis pedis arteries as well as both arms), OR Skin Perfusion Pressure (SPP) >30, OR biphasic PVR OR TBI > 0.60 OR TCPO2 > 30mmHg OR adequate perfusion as demonstrated on florescent angiography, LUNA®).
- Presence of a venous leg ulcer through full skin thickness but not down to muscle, tendon or bone. The largest ulcer will be the index ulcer and the only one included in the study. If other ulcerations are present on the same leg they have to be more than 2 cm apart from the index ulcer.
- Study ulcer has been present for at least one month prior to the initial screening visit, and is excluded if it has undergone 12 months of continuous high strength compression therapy over its duration.
- Study ulcer is a minimum of 2.0 cm2 / maximum of 25 cm2 at the randomization visit.
Key exclusion criteria (18 listed)
- Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
- Study ulcer(s) deemed by the investigator to be caused by a medical condition other than venous insufficiency. These may include, but are not limited to: fungal ulcerations, malignant ulcerations, and ulcerations due to arterial insufficiency.
- Study ulcer exhibits clinical signs and symptoms of infection at the SV (screening visit) or TV1 (Treatment Visit 1).
- Known allergy to the components of the multi-layer compression bandaging, or who cannot tolerate multi-layer compression therapy.
- Study ulcer is suspicious for cancer should undergo an ulcer biopsy to rule out a carcinoma of the ulcer. The patient may be enrolled after a negative biopsy.
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 |
|---|---|---|
| Harvesting Device (CelluTome©)Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone. | Device | Harvesting Device (CelluTome©) |
Primary outcome
Number of Patients With Healed Wounds
Time frame: 12 weeks
Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone
3 secondary outcomes
Wound Area Change at Week 4
Time frame: 4 weeks
Wound Area Change at Week 12
Time frame: 12 weeks
Incidence of Adverse Event
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Thomas Serena, MD principal investigator
SerenaGroup, Inc.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Harvesting Device (CelluTome©) in people with Impaired Wound Healing and Venous Insufficiency of Leg, run by SerenaGroup, Inc. at 18 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 9 inclusion and 18 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 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Yes. Results are posted in the registry (first posted 29 Apr 2020). 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?
Number of Patients With Healed Wounds (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 29 Apr 2020.