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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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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

Intervention / Treatment
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* Biological: NEOX® CORD 1K®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male/female age 18 or older Type 1 or Type 2 diabetes mellitus Signed informed consent Wound present for minimum for four (4) weeks Wound location foot to include the dorsal or plantar surface Serum creatinine < 3.0 mg/dL HbA1c< 12% taken prior to randomization Patient presents with adequate circulation to the effected extremity, as demonstrated by one of the following within sixty (60) days: Ankle-Brachial Index (ABI) with results of >0.6 and <1.2 Doppler arterial waveforms which are triphasic or biphasic at ankle of affected lower extremity Wound is diabetic in origin with and area of > 1 cm2 and < 16 cm2 at time of screening Exclusion Criteria: Unwilling to follow the visit requirements and instructions outlined by the protocol Currently receiving radiation therapy or chemotherapy Non-vascular surgical site The subject's wound can be addressed by primary closure 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 Pregnant or breast feeding HbA1c: > 12% within previous ninety (90) days Serum creatinine level > 3.0 mg/dL Taking medications that are considered immune system modulators Uncontrolled autoimmune surgical sites Known or suspected local skin malignancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Group that will be receiving the investigational product | Biological: NEOX® CORD 1K®<br>* NEOX CORD 1K is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. NEOX CORD 1K is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. NEOX CORD 1K is aseptically processed in compliance with current Good Tissue Practices (cGTP). NEOX CORD 1K of various sizes is stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B (an anti-fungal agent). NEOX CORD 1K will be applied to completely cover the wound area and is maintained stationary with sutures or even negative pressure wound therapy after adequate sharp debridement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete ulcer closure | Proportion of subjects with confirmed complete ulcer closure at sixteen (16) weeks, confirmed by being closed for 30 days. | 16 weeks | 

Secondary Outcome Measures

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