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

NCT02571738 | Terminated Phase 3 DMC

• 1 other identifier: Osiris Protocol 303
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 18

Brief 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

Conditions

Chronic Diabetic Foot Ulcers

Outcome Measures

Primary Outcomes (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

  Up to 112 days after Baseline Visit

Secondary Outcomes (5)

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

  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.

  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.

  Up to 28 days after Baseline

• Number of applications of CHAM versus control

  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

  Up to 91 days after Single-Blind Treatment Phase

Other Outcomes (4)

• Wound re-occurrence for up to 3 months after initial wound closure in patients receiving CHAM versus control.

  Up to 84 days after Single-Blind Treatment Phase

• Number and types of Adverse Events (AE) and Serious Adverse Events (SAE)

  Up to 84 days after Single-Blind Treatment Phase

• Number of patients with worsening of wound defined by a 50% increase in wound size

  Up to 84 days after Baseline

Study Arms (2)

CHAM

ACTIVE COMPARATOR

Cryopreserved Human Amniotic Membrane

Biological: CHAM

Control

PLACEBO COMPARATOR

Standard of Care

Other: Control

Interventions

CHAM BIOLOGICAL

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

CHAM

Control OTHER

Standard of Care

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Osiris Therapeutics: lead

Study Sites (18)

SAVAHCS

Tucson, Arizona, 85723, United States

Location

ILD Research Center

Carlsbad, California, 92009, United States

Location

Center for Clinical Research

Castro Valley, California, 94546, United States

Location

Center for Clinical Research

San Francisco, California, 94115, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

Location

Barry University Clinical Research

North Miami Beach, Florida, 33169, United States

Location

SSH

South Weymouth, Massachusetts, 02190, United States

Location

Ocean County Foot & Ankle Surgical Associates

Toms River, New Jersey, 08753, United States

Location

NSLIJHS

Lake Success, New York, 11042, United States

Location

UNC

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University Orthopedics

Altoona, Pennsylvania, 16602, United States

Location

Temple University

Philadelphia, Pennsylvania, 19107, United States

Location

Spartanburg Regional Healthcare System

Spartanburg, South Carolina, 29303, United States

Location

North Texas Podiatric Medicine and Surgery Associates

Dallas, Texas, 75231, United States

Location

Texas Gulf Coast Medical Group

Webster, Texas, 77598, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: June 1, 2017
• Last Updated: October 6, 2017

Record last verified: 2017-10

Locations

US (18)