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

Chronic Diabetic Foot Ulcers Clinical Trial

— *OTI-15-01  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02571738
• Other study ID #: Osiris Protocol 303
• Status: Terminated
• Phase: Phase 3
• First received: October 6, 2015
• Last updated: October 5, 2017
• Start date: October 2015
• Est. completion date: June 2017

Study information

• Verified date: October 2017
• Source: Osiris Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 108
• Est. completion date: June 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Diabetic Foot Ulcers
• Diabetic Foot
• Foot Ulcer
• Ulcer

Intervention

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

Other:
• Control
Standard of Care

Locations

Country	Name	City	State
United States	University Orthopedics	Altoona	Pennsylvania
United States	ILD Research Center	Carlsbad	California
United States	Center for Clinical Research	Castro Valley	California
United States	UNC	Chapel Hill	North Carolina
United States	Cleveland Clinic	Cleveland	Ohio
United States	North Texas Podiatric Medicine and Surgery Associates	Dallas	Texas
United States	Duke University	Durham	North Carolina
United States	NSLIJHS	Lake Success	New York
United States	Barry University Clinical Research	North Miami Beach	Florida
United States	Temple University	Philadelphia	Pennsylvania
United States	Center for Clinical Research	San Francisco	California
United States	SSH	South Weymouth	Massachusetts
United States	Spartanburg Regional Healthcare System	Spartanburg	South Carolina
United States	Stanford University	Stanford	California
United States	Ocean County Foot & Ankle Surgical Associates	Toms River	New Jersey
United States	SAVAHCS	Tucson	Arizona
United States	MedStar Georgetown University Hospital	Washington, D.C.	District of Columbia
United States	Texas Gulf Coast Medical Group	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Osiris Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Number and types of Adverse Events (AE) and Serious Adverse Events (SAE)		Up to 84 days after Single-Blind Treatment Phase
Other	Number of patients with worsening of wound defined by a 50% increase in wound size		Up to 84 days after Baseline
Other	Change in Quality of Life from Baseline, as determined by the Cardiff Wound Impact Schedule (CWIS)		Up to 84 days after Baseline
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of applications of CHAM versus control		Up to 77 days after Baseline
Secondary	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