Clinical trial NCT03296436: A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds
Official title: A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
Diabetic Foot Ulcer
Diabetic Foot
Diabetic Foot Infection
Diabetic Foot Ulcer Mixed
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-09-28
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: complete ulcer closure
timeFrame: 16 weeks
Secondary outcomes:
measure: NEOX CORD 1K applications
timeFrame: 16 weeks
measure: ulcer surface area
timeFrame: 16 weeks
measure: number of days to complete wound closure
timeFrame: 16 weeks
measure: Mean cost to closure
timeFrame: 16 weeks
measure: recurrent ulcer-related complications
timeFrame: 16 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Rondald Sherman, DPM, MBA
role: PRINCIPAL_INVESTIGATOR
References: