Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K (NCT02707406) | Clinical Trial Compass
CompletedNot Applicable
Non-healing Diabetic Foot Ulcers (DFU) Treated With SoC With or Without NEOX®CORD 1K
United States124 participantsStarted 2016-02
Plain-language summary
The study is evaluating NEOX®CORD 1K, a cryopreserved human umbilical cord allograft.
The purpose of the study is to evaluate the safety, incidence and rate of wound closure following application of the product compared to standard of care in the treatment of difficult to heal diabetic foot ulcers.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patient has signed the informed consent form
* Male or female patient at least 18 years of age or older, as of the date of the screening visit
* Confirmed diagnosis of Type I or Type II Diabetes
* Has an index ulcer that is located below the malleoli on the plantar surface of at least 0.5 cm2 or up to 5.0 cm2 when measured by the investigator staff at the screening visit using the ARANZ Silhouette post debridement.
* The depth of the index foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule
* The index ulcer is "chronic, non-healing," defined as having a duration of \> 4 weeks but not \> 52 weeks at the screening visit
* Arterial supply adequacy to the foot with the index ulcer confirmed by any one of the following:
Great toe pressure ≥ 40 mm/Hg
* Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.65 ≤ 1.20
* TcPO2 ≥ 30 mmHg from the foot •
* Normal triphasic or biphasic waveform pattern at the ankle
* Toe Brachial Index or TBI ≥ 0.50
* Willing to follow all instructions including off-loading given by the Investigator
* Willing to return for all mandatory visits as defined in the protocol
Exclusion Criteria:
* Renal impairment marked by serum creatinine \& serum total BUN \> 2 times the upper limit of normal or is currently receiving renal dialysis
* Hemoglobin A1c (HbA1c) level is \> 12% (108 mmol/mol)
* Has an abnormally low serum albumin, as evidenced by an albumi…
What they're measuring
1
Incidence of adverse events collected throughout the trial compared between the two groups