A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds

Early Phase 1

Withdrawn

• Conditions: Diabetic Foot Ulcer Mixed; Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot); Diabetic Foot Ulcer; Diabetic Foot; Diabetic Foot Infection
• Interventions: Biological: NEOX® CORD 1K®

• Registration Number: NCT03296436
• Lead Sponsor: Johns Hopkins University

Brief Summary

Patients presenting to Johns Hopkins with a diabetic ulcer classified by the UT Grade 2 or 3 who meet all of the inclusion and none exclusion criteria and give their informed consent, will receive an application of NEOX CORD 1K in addition to standard of care procedures. Those patients will be seen in follow-up at weekly visits until the wound closes and epithelize, achieving complete closure. Subjects that do not achieve complete ulcer closure prior to or at the end of the 16 treatment weeks will exit the study.

Detailed Description

A prospective investigator initiated trial will be conducted in diabetic patients with lower extremity wounds managed with NEOX CORD 1K umbilical cord product supplied by Amniox (a subsidiary of TissueTech, Inc.). The patient population will be comprised of Type 1 or Type 2 diabetics presenting to our hospital for the treatment of lower extremity wounds occurring on the dorsal and plantar foot. The wounds will be treated in the Operating Room (OR) arena including surgical debridement, resection of bone necrosis, biopsy, etc. to treat the associated morbidity. These wounds are classified utilizing the University of Texas (UT) Classification System as Grades: 2 (wounds penetrating to tendon or capsule) and 3 (wounds penetrating to bone or joint) with Stages: A (no infection or ischemia), B (Infection present), C (ischemia present) and D (Infection and ischemia present). This morbidity will comprise of complex wounds that exhibit exposed muscle, tendon, bone and may include the presence of treated osteomyelitis. This patient population oftentimes include diabetics with lower extremity ischemia or end stage renal disease and their associated comorbidities. These wounds are challenging in their care being they trend towards a poor prognosis including high morbidity and mortality as well as high major limb amputation rates. Hence, this trial will provide associated data to the efficacy of the above referenced material towards evaluating its effectiveness in these wound types towards enhancing wound healing and subsequently reducing amputation rates.

Study Timeline

• Study First Submitted: 2017-09-25
• Study First Submitted QC: 2017-09-27
• Study First Posted: 2017-09-28
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27
• Study Start: 2020-01
• Primary Completion: 2021-01
• Study Completion: 2021-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Male/female age 18 or older
2. Type 1 or Type 2 diabetes mellitus
3. Signed informed consent
4. Wound present for minimum for four (4) weeks
5. Wound location foot to include the dorsal or plantar surface
6. Serum creatinine < 3.0 mg/dL
7. HbA1c< 12% taken prior to randomization
8. Patient presents with adequate circulation to the effected extremity, as demonstrated
9. by one of the following within sixty (60) days:
10. Ankle-Brachial Index (ABI) with results of >0.6 and <1.2
11. Doppler arterial waveforms which are triphasic or biphasic at ankle of affected lower extremity
12. Wound is diabetic in origin with and area of > 1 cm2 and < 16 cm2 at time of screening

Exclusion Criteria

13. Unwilling to follow the visit requirements and instructions outlined by the protocol
14. Currently receiving radiation therapy or chemotherapy
15. Non-vascular surgical site
16. The subject's wound can be addressed by primary closure
17. Received growth factors, living skin, dermal substitutes, silver-containing products, amniotic membrane or umbilical cord products or other advanced biological therapies for wounds within 30 days of screening
18. Pregnant or breast feeding
19. HbA1c: > 12% within previous ninety (90) days
20. Serum creatinine level > 3.0 mg/dL Taking medications that are considered immune system modulators
21. Uncontrolled autoimmune surgical sites
22. Known or suspected local skin malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Group	NEOX® CORD 1K®	Group that will be receiving the investigational product

Primary Outcome Measures

Name	Time	Method
complete ulcer closure	16 weeks	Proportion of subjects with confirmed complete ulcer closure at sixteen (16) weeks, confirmed by being closed for 30 days.

Secondary Outcome Measures

Name	Time	Method
recurrent ulcer-related complications	16 weeks	• Proportion of subjects who experience recurrent ulcer-related complications (e.g., sepsis, osteomyelitis, limb amputation)
NEOX CORD 1K applications	16 weeks	Total number of NEOX CORD 1K applications the subject received over the treatment period
Mean cost to closure	16 weeks	Mean cost to closure
ulcer surface area	16 weeks	Percent change in the ulcer surface area (cm2) at each visit from baseline
number of days to complete wound closure	16 weeks	Time in number of days to complete wound closure over the 16-week treatment period