Diabetic Foot UlcerDFUsNCT03855514
Randomized Clinical Study Assessing NuShield Versus Standard of Care in Diabetic Foot Ulcers
A study testing NuShield in people with Diabetic Foot Ulcer, run by Organogenesis at 9 sites in United States.
Trial summary
This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- NuShield
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 9 sitesUnited States
- Study dates
- 8 Feb 2019to 30 Dec 2021
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years old and maximum of 85 years old.
- Subjects with a diabetic foot ulcer that is either superficial, e.g. not involving tendon, capsule, or bone; or wounds that penetrate into tendon, capsule, bone and/or joint.
- Subjects, with the presence of Diabetes, must have a Glycosylated hemoglobin (HbA1c) ≤ 12% within 4 weeks prior to randomization
- Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit with no upper limit in duration of non-healing.
- Subject has adequate circulation to the foot as documented by either: Skin perfusion pressure (SPP) measurement of ≥ 45 mmHg, Toe-brachial index (TBI) ≥ 0.6/ Toe pressure greater than 40, Ankle-brachial index (ABI) between 0.60 and ≤ 1.3
- Index ulcer is a minimum of 0.5 cm2 and a maximum of 25cm2 at randomization, prior to first study treatment.
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- The index ulcer has been offloaded for 14 days prior to randomization.
- Index ulcer has not reduced in area > 20% from Day -14 to Day 0, prior to randomization.
- Subject understands and is willing to participate in the clinical study and can comply with weekly visits and the follow-up regimen.
- Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
Who cannot join
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- Treatment with HBO wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 30 days of randomization.
- History of bone cancer or metastatic disease of the affected limb or chemotherapy within the 12 months prior to randomization.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including prednisone 10 mg daily or an equivalent does of other oral steroids cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
- History of radiation at the ulcer site.
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- Index ulcer has been previously treated or will need to be treated with any prohibited therapies within 30 days prior to randomization.
- 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.
- Active infection at the index ulcer at the time of Randomization.
- Acute osteomyelitis or bone infection of the affected foot, where subject has received less than 4 weeks of systemic antibiotics at the time of Screening and less than 6 weeks prior to Randomization (systemic antibiotic regimen must be completed at the time of Randomization).
- Subject's with suspected infection who have received less than 2 weeks of systemic antibiotics, or have not had surgical resection of clinically diagnosed osteomyelitis
- Subjects with suspected osteomyelitis who have not had an X-ray, CT scan or MRI within 14 days prior to Randomization.
- Subject is unwilling or unable to comply with the study requirement for offloading the index wound
- Subject is pregnant or breast feeding.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Family Foot & Ankle Specialists
Bridgeport, Connecticut, 06606
Catherine Porter, familypodiatryct@gmail.com
Daniel Davis
- Recruiting
ILD Research Center
Carlsbad, California, 92002
Eric Martinez, eric@ildresearch.com
Dean Vayser, DPM
- Recruiting
Limb Preservation Platform
Fresno, California, 94063
Destiny Blackstone, destiny@lppresearch.com
Shawn Cazzell
- Recruiting
University of Southern California
Los Angeles, California, 91208
Karen DHuyvetter, Karen.DHuyvetter@med.usc.edu
David Armstrong
- Recruiting
Futuro Clinical Trials
McAllen, Texas, 78501
Chrissy Rodriguez, chrissycffc@gmail.com
Joseph Caporusso
- Recruiting
Doctors Research Network
Miami, Florida, 33143
Nara Neiva, nneiva@miamifoot.com
Jason Hanft
- Recruiting
NYU Winthrop Hospital
New York, New York, 11501
Helen Yiu, helen.yiu@nyulangone.org
Scott Gorenstein
- Recruiting
Stanford University
Redwood City, California, 94063
Shannon Meyer, smeyer27@stanford.edu
Geoffrey Gurtner
- Recruiting
Extremity Healthcare
Roswell, Georgia, 30076
Amelia Sobhani, asobhani@vpcenters.com
Ira Kraus
About this study
Official title: A Prospective, Multicenter, Randomized, Controlled Clinical Study Of NuShield® and Standard of Care (SOC) Compared to SOC Alone For The Management Of Diabetic Foot Ulcers
This prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy.
Read the detailed description
Two hundred (200) subjects with a chronic DFU ranging in size from 0.5cm2 and 25 cm2 will be randomized 1:1 to either NuShield® and SOC or SOC alone following the 14 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.
Subjects that are randomized into the SOC group whose DFU has not healed by week 12 may be crossed over to receive NuShield® and followed for an additional 12-14 weeks.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- NuShield
- Keywords
- DFU, Chronic Diabetic Foot Ulcer, Non-healing DFU
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuShieldOther
NuShield® is a dehydrated placental allograft.
| Study group | Role | What they receive |
|---|---|---|
| NuShield | Active comparator | NuShield® is a sterile, dehydrated placental allograft Receives: Other: NuShield |
| Standard of Care | No intervention | Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of time that a wound achieves complete wound closure (CWC)
Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups
Measured: 12 weeks
Secondary outcomes (7)
Greater than 40% wound closure at week 4 from baseline
Proportion of subjects achieving ≥ 40% wound closure at Week 4 from baseline
Measured: 4 weeks
Change in wound area
Mean percent change from baseline in wound area at Week 12
Measured: 12 weeks
Incidence of prescribed pain and/or neuropathic medications
Cumulative amount of pain and neuropathic medications taken between baseline and Week 12 assessed between both groups.
Measured: 12 weeks
Reduction in subject reported pain at week 12 from baseline assessed between both groups via the Numeric Pain Rating Scale (NPRS)
Mean percent change at week 12 in subject reported pain, assessed via the NPRS pain scale where 0 = no pain and 10 = worst pain imaginable, on a scale of 0 to 10.
Measured: 12 weeks
Utilization of healthcare resources assessment
Utilization of healthcare resources through Week 12
Measured: 12 weeks
Improvement in subject reported quality of life at week 12 from baseline assessed via the Wound-QoL (Questionnaire on quality of life with chronic wounds).
Mean percent change at week 12 from baseline in subject reported quality of life scores between both groups. The 17 item Wound-QoL tool measures the disease-specific, health-related quality of life of patients with chronic wounds. A global score is computed by averaging all 17 items where subjects answer each question on a scale of 0 to 4, where 0=not at all and 4=very much.
Measured: 12 weeks
Time to complete wound closure (CWC) by or on 24 weeks
Length of time wounds achieve CWC at week 24 from baseline
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start8 Feb 2019
- Primary completionNov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christine McLennan, Study director, Organogenesis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03855514
- Sponsor's protocol ID
- 18-DFU-005-NUS
- Acronym
- DFUs
- Status last verified
- May 2021
- First submitted
- 22 Feb 2019
- Last updated
- 26 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Controlled Clinical Study Of NuShield® and Standard of Care (SOC) Compared to SOC Alone For The Management Of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT03855514
- Acronym / sponsor ID
- DFUs / 18-DFU-005-NUS
- Conditions
- Diabetic Foot Ulcer
- Keywords
- DFU, Chronic Diabetic Foot Ulcer, Non-healing DFU
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2019 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 26 Feb 2019 (actual)
- 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 prospective, multi-center, randomized, controlled clinical study compares NuShield® plus SOC to SOC alone in subjects with chronic DFUs. NuShield® will be used along with standard of care on diabetic foot ulcers of greater than 6 weeks which have not adequately responded to conventional ulcer therapy.
Detailed description
Two hundred (200) subjects with a chronic DFU ranging in size from 0.5cm2 and 25 cm2 will be randomized 1:1 to either NuShield® and SOC or SOC alone following the 14 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.
Subjects that are randomized into the SOC group whose DFU has not healed by week 12 may be crossed over to receive NuShield® and followed for an additional 12-14 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuShield | Active comparator | Other: NuShieldNuShield® is a sterile, dehydrated placental allograft |
| Standard of Care | No intervention | –Standard of Care (SOC) includes, but is not limited to, surgical debridement, aggressive infection management, offloading, and maintenance of appropriate cleansing at the time of each dressing change. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- At least 18 years old and maximum of 85 years old.
- Subjects with a diabetic foot ulcer that is either superficial, e.g. not involving tendon, capsule, or bone; or wounds that penetrate into tendon, capsule, bone and/or joint.
- Subjects, with the presence of Diabetes, must have a Glycosylated hemoglobin (HbA1c) ≤ 12% within 4 weeks prior to randomization
- Index ulcer (i.e. current episode of ulceration) has been present for greater than 4 weeks prior to the initial screening visit with no upper limit in duration of non-healing.
- Subject has adequate circulation to the foot as documented by either: Skin perfusion pressure (SPP) measurement of ≥ 45 mmHg, Toe-brachial index (TBI) ≥ 0.6/ Toe pressure greater than 40, Ankle-brachial index (ABI) between 0.60 and ≤ 1.3
Key exclusion criteria (14 listed)
- Index ulcer(s) deemed by the investigator to be caused by a medical condition other than diabetes.
- Treatment with HBO wound dressings that include growth factors, bioengineered tissues, or skin substitutes within 30 days of randomization.
- History of bone cancer or metastatic disease of the affected limb or chemotherapy within the 12 months prior to randomization.
- Subjects with a history of more than two weeks treatment with immunosuppressants (including prednisone 10 mg daily or an equivalent does of other oral steroids cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to first Screening Visit, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
- Subject is on any investigational drug(s) or therapeutic device(s) within 30 days preceding the first Screening Visit.
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 |
|---|---|---|
| NuShieldNuShield® is a dehydrated placental allograft. | Other | NuShield |
Primary outcome
Length of time that a wound achieves complete wound closure (CWC)
Time frame: 12 weeks
Duration (number of days) to achieve CWC from baseline to week 12 assessed between both groups
7 secondary outcomes
Greater than 40% wound closure at week 4 from baseline
Time frame: 4 weeks
Change in wound area
Time frame: 12 weeks
Incidence of prescribed pain and/or neuropathic medications
Time frame: 12 weeks
Reduction in subject reported pain at week 12 from baseline assessed between both groups via the Numeric Pain Rating Scale (NPRS)
Time frame: 12 weeks
Utilization of healthcare resources assessment
Time frame: 12 weeks
Improvement in subject reported quality of life at week 12 from baseline assessed via the Wound-QoL (Questionnaire on quality of life with chronic wounds).
Time frame: 12 weeks
Time to complete wound closure (CWC) by or on 24 weeks
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
- Individual participant dataSharing planned: No
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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.
Christine McLennan study director
Organogenesis Inc.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuShield in people with Diabetic Foot Ulcer, run by Organogenesis 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 10 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 26 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galen Hale ((205) 541-9682, GHale@organo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of time that a wound achieves complete wound closure (CWC) (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 26 May 2021.