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Chronic Diabetic Foot UlcersPhase 3*OTI-15-01NCT02571738

Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers

A Phase 3 study testing CHAM in people with Chronic Diabetic Foot Ulcers, run by Osiris Therapeutics at 18 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Chronic Diabetic Foot Ulcers
What is being tested?
CHAM
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
18 sitesUnited States
Study dates
Oct 2015to Jun 2017
Phase
Phase 3
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Between 18 years and 80 years of age inclusive, as of the date of screening
  • Confirmed diagnosis of Type I or Type II Diabetes
  • An Index Ulcer defined as chronic (presence of wound for > 4 weeks), but not present for more than 52 weeks at the Screening Visit
  • Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
  • The Index Ulcer is between 1 cm2 and 15 cm2, inclusive, at the Screening Visit
  • The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
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  • Wound is free of necrotic debris
  • Patient has adequate circulation to the foot as documented by either:
  • Ankle Brachial Index (ABI) > 0.70 and < 1.30, or
  • In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30, a Toe Brachial Index (TBI) ≥ 0.50, or
  • In patients with non-compressible ankle vessels defined as an ABI ≥ 1.30 and TBI cannot be performed (e.g., toe is absent, wounds are present, or site cannot perform a TBI), a Doppler waveform in the posterior tibial or dorsalis pedis arteries at the ankle consistent with adequate flow in the foot (biphasic or triphasic) and other diagnostic confirmation of adequate flow (e.g., duplex imaging, normal pulse volume recording [PVR] testing).

Who cannot join

  • Index Ulcer is of non-diabetic pathophysiology
  • Gangrene is present on any part of the affected foot
  • Index Ulcer is over an active Charcot deformity
  • The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
  • Patient is currently receiving dialysis or planning to go on dialysis
  • Patient has had 2 or more previous disease-related amputations of the lower extremities
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  • Patient has a glycated hemoglobin A1c (HbA1c) level of >10%
  • Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
  • Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
  • Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
  • Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
  • Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
  • Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
  • Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
  • Patient has active malignancy other than non-melanoma skin cancer
  • Patient's Index Ulcer has decreased by ≥20% during 1-week screening period
  • Patient's random blood sugar is >350 mg/dl at screening
  • Patient has untreated alcohol or substance abuse at the time of screening
  • Pregnant women and women who are breastfeeding
  • Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
  • Patient has had within the last 30 days, or is currently undergoing, or is planning for wound treatments with growth factors, living skin, dermal substitutes or other advanced biological therapies
  • Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
  • Patients who have already been randomized in Protocol 303 at any center may not be considered for screening or for re-entry into the trial at any center, even after the end of their follow-up period
  • Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol.

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

United States18 sites

  • University Orthopedics

    Altoona, Pennsylvania, 16602

  • ILD Research Center

    Carlsbad, California, 92009

  • Center for Clinical Research

    Castro Valley, California, 94546

  • UNC

    Chapel Hill, North Carolina, 27599

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • North Texas Podiatric Medicine and Surgery Associates

    Dallas, Texas, 75231

  • Duke University

    Durham, North Carolina, 27710

  • NSLIJHS

    Lake Success, New York, 11042

  • Barry University Clinical Research

    North Miami Beach, Florida, 33169

  • Temple University

    Philadelphia, Pennsylvania, 19107

  • Center for Clinical Research

    San Francisco, California, 94115

  • SSH

    South Weymouth, Massachusetts, 02190

  • Spartanburg Regional Healthcare System

    Spartanburg, South Carolina, 29303

  • Stanford University

    Stanford, California, 94305

  • Ocean County Foot & Ankle Surgical Associates

    Toms River, New Jersey, 08753

  • SAVAHCS

    Tucson, Arizona, 85723

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Texas Gulf Coast Medical Group

    Webster, Texas, 77598

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Single-Blind Study With an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers

A Multicenter, Randomized, Single-Blind Study with an Open-Label Extension Option to Further Evaluate the Safety and Efficacy of Cryopreserved Human Amniotic Membrane for the Treatment of Chronic Diabetic Foot Ulcers

Being tested
CHAM, Control

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CHAMBiological

    The treatment indication is for chronic diabetic foot ulcers that can accommodate up to one 5cm x 5cm piece of CHAM

  • ControlOther

    Standard of Care

Study groups in NCT02571738
Study groupRoleWhat they receive
CHAMActive comparatorCryopreserved Human Amniotic Membrane
Receives: Biological: CHAM
ControlPlacebo comparatorStandard of Care
Receives: Other: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, by the End of Single-Blind Treatment Visit with follow-up confirmation of continued closure at 2 consecutive study visits 2 weeks apart

    Measured: Up to 112 days after Baseline Visit

Secondary outcomes (5)

  1. Complete index wound closure by the End of Single-Blind Treatment Visit as defined by 100% re-epithelialization, as determined by the Investigator.

    Measured: Up to 84 days after Baseline Visit

  2. Time to initial wound closure among patients that receive CHAM versus those that receive control as measured by Kaplan-Meier analysis.

    Measured: Up to 84 days after Baseline Visit

  3. Proportion of patients receiving CHAM that achieve a 50% reduction or greater in wound size by Day 28 (± 3 days) versus those that receive control.

    Measured: Up to 28 days after Baseline

  4. Number of applications of CHAM versus control

    Measured: Up to 77 days after Baseline

  5. Percentage of patients who achieve complete wound closure, defined as 100% re-epithelialization as determined by the Investigator, who participate in the Open-Label Treatment Phase

    Measured: Up to 91 days after Single-Blind Treatment Phase

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionApr 2017
  4. Study completionJun 2017

Why it stopped: Company's desire to allocate more research and development resources to other clinical programs. Decision not driven by any safety concerns.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02571738
Sponsor's protocol ID
Osiris Protocol 303
Acronym
*OTI-15-01
Status last verified
Oct 2017
First submitted
6 Oct 2015
Last updated
6 Oct 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CHAM in people with Chronic Diabetic Foot Ulcers, run by Osiris Therapeutics 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 11 inclusion and 24 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 6 Oct 2017. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 stopped early (reason given: Company's desire to allocate more research and development resources to other clinical programs. Decision not driven by any safety concerns.). 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?

Complete closure of the index wound, defined as 100% re-epithelialization as determined by the Investigator, by the End of Single-Blind Treatment Visit with follow-up confirmation of continued closure at 2 consecutive study visits 2 weeks apart (time frame: Up to 112 days after Baseline Visit). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02571738.

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 6 Oct 2017.

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