N/A
N=40
Characterization of AmnioExcel Plus in Two Treatment Paradigms
Diabetic Foot Ulcer
Bottom Line
View on ClinicalTrials.gov: NCT04233580 ↗Enrolled (actual)
40
Serious AEs
27.5%
Results posted
Sep 2022
Primary outcome: Primary: Number of Participants Who Healed — 6; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Amnio Excel + weekly (Device); Amnio Excel + max every 2 weeks (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Healed |
6; 10 | — |
| SECONDARY Wound Volume |
1.2; 0.53 | — |
| SECONDARY Wound Area |
3.98; 3.15 | — |
| SECONDARY Tissue Oxygenation (StO2) of the Dorsal Foot |
65.89; 65.70 | — |
Summary
The Investigators plan to evaluate healing in two cohorts of patients with diabetic foot wounds (n=20) that receive optimal treatment including serial wound debridement and off-loading with a boot or postop shoe and AmnioEXCEL+. In one cohort, AmnioEXCEL+ will be applied weekly at study visits and in the second cohort, AmnioEXCEL+ will be applied maximum every 2 weeks (PRN, in the case that the wound requires debridement at a visit not intended for AE+ application, the wound will be treated as SOC). In addition, the Investigators will collect data on other potential confounding factors that could affect healing such as antibiotic, anti-fungal and anti-infective medications, tobacco, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated.
Eligibility Criteria
Criteria for Inclusion of Subjects:
- 21-90 years of age
- Able to provide informed consent
- Chronic foot ulceration below the ankle - persistent for >30 days but 90 years of age
- Unable to provide informed consent
- History of poor compliance in the opinion of the investigator
- Gangrene
- Untreated osteomyelitis
- Widespread malignancy
- Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines that in the opinion of the investigator will impact the subject's participation in the study
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT04233580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.