An interventional study of Harvesting Device (CelluTome©) in Impaired Wound Healing, Venous Insufficiency of Leg and Diabetic Ulcers, sponsored by SerenaGroup, Inc.. Terminated at 18 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-29.
Sponsored by SerenaGroup, Inc. · Not applicable, Interventional, and Treatment
Among 141 studies in Ulcer with a site in United States — 24 open to participants now, 27 under way, none of them phase 3. Ulcer · United States.
Among the 141 studies in Ulcer with a site in United States, this one is the 47th largest by enrollment of the 124 interventional ones that give a count, is one of 6 that started in 2014, is one of 60 with no phase, and was the 65th registered.
359 studies on the registry are indexed under Ulcer; 62 are open to participants now.
Browse Ulcer studies →24 of the 141 studies in Ulcer with a site in United States are open now. Recruiting first, the newest first:
Pfizer · Sites in United States, Australia, Canada and 7 more countries
Ages 2–11
Athos Therapeutics Inc · Sites in United States
Ages 18–75
Sequence LifeScience, Inc. · Sites in United States
Ages 18+
BioLab Holdings · Sites in United States
Ages 18+
Applied Biologics, LLC · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 39 Ulcer studies recruiting now, 29 (74%) set no upper age limit and 4 (10%) stop at 75 or younger; 4 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
141 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 8 · Phase 2 32 · Phase 3 18 · Phase 4 10
First in 1994; this study’s year is marked. 6 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 123 is above the median of 65 across 291 interventional studies indexed under Ulcer.
Median enrollment 95 across the 124 interventional studies, 87 across the 16 observational. Of the 97 that completed or were terminated, 43 (44%) have results posted.
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95 of 141 have an industry lead sponsor. The 10 most frequent:
SerenaGroup, Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
SerenaGroup, Inc. has 1 study filed under Ulcer — fewer than ten, so there is no comparison to draw.
14 of the studies in Ulcer with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06681428Tides MedicalRising Tide - Amniotic Tissue(s) Treatments for Chronic Diabetic Foot Ulcers | 2026-11-18 |
| NCT06674980C5 BiomedicalClinical Trial Assessing Human Placental Membrane Products and Standard of Care Versus Standard of Care in Nonhealing DFUs and VLUs | 2026-11-22 |
| NCT05739149Mayo ClinicA Study to Evaluate Microvessel Ultrasound Imaging of Wound Healing in Patients With Chronic Ulcers | 2026-12-10 |
| NCT07364630BioLab HoldingsEfficacy of Human Placental Membrane Products and Standard of Care in the Management of Nonhealing Diabetic Foot Ulcers and Venous Leg Ulcers | 2027-01 |
| NCT06616844ConvaTec Inc.IDEAL: Efficacy of Porcine Placental Extracellular Matrix Augmented Plus Standard of Care (SOC) Versus SOC Alone for the Management of Diabetic Foot Ulcers | 2027-03 |
Among the 141 studies in Ulcer with a site in United States, from their registry updates:
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Potential subjects meeting any of the following criteria will be excluded from enrollment and subsequent randomization.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Harvesting Device (CelluTome©)
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).
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.
Number of Patients With Healed Wounds
Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone
Time frame: 12 weeks
Wound Area Change at Week 4
Percentage of wound area change at week 4
Time frame: 4 weeks
Wound Area Change at Week 12
Percentage of wound area change at Week 12
Time frame: 12 weeks
Incidence of Adverse Event
Incidence of adverse events with epidermal grafting versus standard of care.
Time frame: 12 weeks
| Milestone | Harvesting Device (CelluTome©) | Control: SOC Alone |
|---|---|---|
| Started | 57 | 66 |
| Completed | 57 | 66 |
| Not completed | 0 | 0 |
Number of patients experiencing wound healing with epidermal grafting and standard of care vs. standard of care alone
| participants | Harvesting Device (CelluTome©) | Control: SOC Alone |
|---|---|---|
| Number of Patients With Healed Wounds | 11 | 16 |
Percentage of wound area change at week 4
| percentage of area change | Harvesting Device (CelluTome©) | Control: SOC Alone |
|---|---|---|
| Wound Area Change at Week 4 | 26.8 ± 20.24 | 27.2 ± 24.12 |
Percentage of wound area change at Week 12
| percentage of area change | Harvesting Device (CelluTome©) | Control: SOC Alone |
|---|---|---|
| Wound Area Change at Week 12 | 41.7 ± 21 | 47.4 ± 21.5 |
Incidence of adverse events with epidermal grafting versus standard of care.
| percentage of participants | Harvesting Device (CelluTome©) | Control: SOC Alone |
|---|---|---|
| Incidence of Adverse Event | 28 | 27 |
Collected over Adverse event data was collected from enrollment to subject completion (12 weeks).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Harvesting Device (CelluTome©) | 0/57 (0%) | 5/57 (8.8%) | 15/57 (26.3%) |
| Control: SOC Alone | 0/66 (0%) | 6/66 (9.1%) | 17/66 (25.8%) |
| Event | Harvesting Device (CelluTome©) | Control: SOC Alone |
|---|---|---|
| InfectionSkin and subcutaneous tissue disorders | 5/57 | 6/66 |
| Event | Harvesting Device (CelluTome©) | Control: SOC Alone |
|---|---|---|
| ColdGeneral disorders | 15/57 | 17/66 |
| Age, Categorical(Participants) | Harvesting Device (CelluTome©) | Control: SOC Alone | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 37 | 41 | 78 |
| >=65 years | 20 | 25 | 45 |
| Sex: Female, Male(Participants) | Harvesting Device (CelluTome©) | Control: SOC Alone | Total |
|---|---|---|---|
| Female | 32 | 37 | 69 |
| Male | 25 | 29 | 54 |
| Ethnicity (NIH/OMB)(Participants) | Harvesting Device (CelluTome©) | Control: SOC Alone | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 2 | 3 |
| Not Hispanic or Latino | 56 | 64 | 120 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Harvesting Device (CelluTome©) | Control: SOC Alone | Total |
|---|---|---|---|
| United States | 52 | 66 | 118 |
| Colombia | 5 | 0 | 5 |
| Area at Screening Visit(cm^2) | Harvesting Device (CelluTome©) | Control: SOC Alone | Total |
|---|---|---|---|
| Mean | 8.48 ± 6.72 | 7.59 ± 6.81 | 8.04 ± 6.76 |
PDFs hosted by the registry, ClinicalTrials.gov.
The record gives a start of May 2014, a primary completion of Nov 2017 and a completion of Nov 2017. It does not say whether these dates are actual or estimated.
Results were first posted in Apr 2020, 2 years 5 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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SerenaGroup, Inc.