Evaluating the Efficacy NeoThelium FT in the Treatment of Diabetic Foot Ulcers
ConditionDiabetic Foot Ulcer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuScience Medical Biologics, LLC
About this trial
This is a randomized controlled crossover trial evaluating the efficacy of NeoThelium FT in conjunction with standard of care vs. standard of care alone in treating diabetic foot ulcers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or Female, 18 years of age or older
Subject has a medical diagnosis of Type I or Type II Diabetes Mellitus requiring oral or glycemic control and/or insulin replacement therapy
Subject has a diabetic foot ulcer present for 4 weeks or greater (documented in medical record), and less than 12 months duration if being treated with continuous SOC
Subject has a diabetic foot ulcer with a historical wound measurement showing less than 25% healing in 14 days prior to screening
Disqualifiers
Subject has a known life expectance of <1 year
Subject is unable to comply with protocol treatment
Subject has major uncontrolled medical disorders in the opinion of the investigator, such as serious cardiovascular, renal, liver, pulmonary, autoimmune, palliative care, or inherited blood disorders that may affect wound healing
Subject actively being treated for malignant disease or history of malignancy or radiation therapy at the site of wound
Trial design
Design model
Crossover
Treatments tested in this trial
Standard of Care
Other interventionWound cleansing, Sharps debridement, Dressing for moisture balance, Offloading
NeoThelium FT
Other interventionNeoThelium FT is a dehydrated wound covering derived from donated human placental tissue. NeoThelium FT is a dual-layer membrane with amnion and chorion combination layers.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: No Intervention: Standard of CareActive comparator 1 intervention
Group B: Intervention: NeoThelium FT & Standard of CareExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Wound Closure
The primary endpoint will be the percentage of target ulcers that achieve complete wound closure.
Time frame
1-12 weeksSecondary outcomes
1
Percentage Wound Area Change
The percentage change in wound area from TV-1 to TV-13 will be measured weekly using digital photographic planimetry and physical examination.
Time frame
1-12 weeks2
Pain Assessment
Change in pain associated with the target ulcer will be assessed using the Numeric Pain Rating Scale at designated time points
Time frame
Day 0, Day 14, Day 35, Day 56, Day 84Other outcomes
1
Hemoglobin A1c
Incidence of wound closure vs HbA1c
Time frame
Day -14 through 91 days2
Adverse Events and Serious Adverse Events
The number and nature of adverse events (AEs) and series adverse events (SAEs) occurring during the study will be tracked and reported.
Time frame
Day -14 through 91 days3
Time to Closure
Average number of grafts/weeks used to achieve wound closure
Time frame
1-12 weeks4
Follow-Up Closure
Number of wounds remaining closed during the 2-week follow-up
Time frame
2 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
NuScience Medical Biologics, LLC
Lead sponsor
SygNola, LLC
Collaborator
Source ClinicalTrials.gov