Status:
WITHDRAWN
A Pilot Study to Assess the Efficacy of NEOX® CORD 1K® in the Treatment of Complex Diabetic Wounds
Lead Sponsor:
Johns Hopkins University
Conditions:
Vascular Ulcer (Arterial or Venous Including Diabetic Ulcers Not Located on the Foot)
Diabetic Foot Ulcer
Eligibility:
All Genders
18-100 years
Phase:
EARLY_PHASE1
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 ...
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 Tissu...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03296436
Start Date
January 1 2020
End Date
October 1 2021
Last Update
February 27 2019
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