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Trial record 1 of 1 for:    NCT02571738
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Study to Evaluate the Safety and Efficacy of CHAM* for the Treatment of Diabetic Foot Ulcers (*OTI-15-01)

This study has been terminated.
(Company's desire to allocate more research and development resources to other clinical programs. Decision not driven by any safety concerns.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02571738
First Posted: October 8, 2015
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Osiris Therapeutics
  Purpose
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

Condition Intervention Phase
Chronic Diabetic Foot Ulcers Biological: CHAM Other: Control Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Osiris Therapeutics:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Complete index wound closure by the End of Single-Blind Treatment Visit as defined by 100% re-epithelialization, as determined by the Investigator. [ Time Frame: Up to 84 days after Baseline Visit ]
  • Time to initial wound closure among patients that receive CHAM versus those that receive control as measured by Kaplan-Meier analysis. [ Time Frame: Up to 84 days after Baseline Visit ]
  • 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. [ Time Frame: Up to 28 days after Baseline ]
  • Number of applications of CHAM versus control [ Time Frame: Up to 77 days after Baseline ]
  • 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 [ Time Frame: Up to 91 days after Single-Blind Treatment Phase ]

Other Outcome Measures:
  • Wound re-occurrence for up to 3 months after initial wound closure in patients receiving CHAM versus control. [ Time Frame: Up to 84 days after Single-Blind Treatment Phase ]
  • Number and types of Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Up to 84 days after Single-Blind Treatment Phase ]
  • Number of patients with worsening of wound defined by a 50% increase in wound size [ Time Frame: Up to 84 days after Baseline ]
  • Change in Quality of Life from Baseline, as determined by the Cardiff Wound Impact Schedule (CWIS) [ Time Frame: Up to 84 days after Baseline ]

Enrollment: 108
Actual Study Start Date: October 2015
Study Completion Date: June 2017
Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: CHAM
Cryopreserved Human Amniotic Membrane
Biological: CHAM
The treatment indication is for chronic diabetic foot ulcers that can accommodate up to one 5cm x 5cm piece of CHAM
Placebo Comparator: Control
Standard of Care
Other: Control
Standard of Care

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 18 years and 80 years of age inclusive, as of the date of screening
  2. Confirmed diagnosis of Type I or Type II Diabetes
  3. An Index Ulcer defined as chronic (presence of wound for > 4 weeks), but not present for more than 52 weeks at the Screening Visit
  4. Index Ulcer is located below the malleoli on the plantar or dorsal surface of the foot
  5. The Index Ulcer is between 1 cm2 and 15 cm2, inclusive, at the Screening Visit
  6. The Index Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule
  7. Wound is free of necrotic debris
  8. 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).

Exclusion Criteria:

  1. Index Ulcer is of non-diabetic pathophysiology
  2. Gangrene is present on any part of the affected foot
  3. Index Ulcer is over an active Charcot deformity
  4. The longest dimension of the Index Ulcer exceeds 5 cm at the Baseline Visit
  5. Patient is currently receiving dialysis or planning to go on dialysis
  6. Patient has had 2 or more previous disease-related amputations of the lower extremities
  7. Patient has a glycated hemoglobin A1c (HbA1c) level of >10%
  8. Chronic oral steroid use >7.5 mg daily for longer than 3 months at the time of screening
  9. Patient is receiving IV corticosteroids, immunosuppressive or cytotoxic agents at the time of screening
  10. Requiring intravenous (IV) antibiotics to treat the index wound infection at the time of screening
  11. Patient has an ulcer within 5 cm of the Index Ulcer identified for study consideration
  12. Patient is Human Immunodeficiency Virus (HIV) positive or has Acquired Immune Deficiency Syndrome (AIDS)
  13. Current evidence of cellulitis, or other evidence of infection including fever or pus drainage from the wound site
  14. Current evidence of osteomyelitis or history of osteomyelitis within 30 days of screening
  15. Patient has active malignancy other than non-melanoma skin cancer
  16. Patient's Index Ulcer has decreased by ≥20% during 1-week screening period
  17. Patient's random blood sugar is >350 mg/dl at screening
  18. Patient has untreated alcohol or substance abuse at the time of screening
  19. Pregnant women and women who are breastfeeding
  20. Patient is currently enrolled or participated in another investigational device, drug, or biological trial within 30 days of screening
  21. 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
  22. Patient is an employee, or an immediate family member of an employee, of the sponsor company or site research staff conducting the study
  23. 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
  24. Patients with a history of poor compliance, or an unwillingness or inability to adhere to the requirements of the protocol.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02571738


Locations
United States, Arizona
SAVAHCS
Tucson, Arizona, United States, 85723
United States, California
ILD Research Center
Carlsbad, California, United States, 92009
Center for Clinical Research
Castro Valley, California, United States, 94546
Center for Clinical Research
San Francisco, California, United States, 94115
Stanford University
Stanford, California, United States, 94305
United States, District of Columbia
MedStar Georgetown University Hospital
Washington, D.C., District of Columbia, United States, 20007
United States, Florida
Barry University Clinical Research
North Miami Beach, Florida, United States, 33169
United States, Massachusetts
SSH
South Weymouth, Massachusetts, United States, 02190
United States, New Jersey
Ocean County Foot & Ankle Surgical Associates
Toms River, New Jersey, United States, 08753
United States, New York
NSLIJHS
Lake Success, New York, United States, 11042
United States, North Carolina
UNC
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University Orthopedics
Altoona, Pennsylvania, United States, 16602
Temple University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, United States, 29303
United States, Texas
North Texas Podiatric Medicine and Surgery Associates
Dallas, Texas, United States, 75231
Texas Gulf Coast Medical Group
Webster, Texas, United States, 77598
Sponsors and Collaborators
Osiris Therapeutics
  More Information

Responsible Party: Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT02571738     History of Changes
Other Study ID Numbers: Osiris Protocol 303
First Submitted: October 6, 2015
First Posted: October 8, 2015
Last Update Posted: October 6, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Ulcer
Diabetic Foot
Foot Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases