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

NCT03296436 | Withdrawn Early Phase 1 DMC

• 1 other identifier: IRB00145403
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• NEOX CORD 1K applications

  16 weeks

• ulcer surface area

  16 weeks

• number of days to complete wound closure

  16 weeks

• Mean cost to closure

  16 weeks

• recurrent ulcer-related complications

  16 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Group that will be receiving the investigational product

Biological: NEOX® CORD 1K®

Interventions

NEOX® CORD 1K® BIOLOGICAL

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.

Treatment Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Rondald Sherman, DPM, MBA

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2017
• First Posted: September 28, 2017
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: October 1, 2021
• Last Updated: February 27, 2019

Record last verified: 2019-02