Diabetic Foot Ulcer
Conditions
Brief summary
A Prospective, Non-Randomized, Multi-Center Observational Study To determine the safety and effectiveness of InnovaMatrix AC porcine placental ECM therapy for the treatment of chronic, non-healing diabetic foot ulcers (DFUs) Eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
Detailed description
This is a prospective, multi-center observational study . The trial will include 30 completed subjects at three (3) experienced clinical centers in the United States. The estimated enrollment period is 13 weeks. After completing a screening , the subjects will be enrolled and receive treatment followed for at least 12 weeks. It is expected that the majority of the subjects will be recruited from patients being seen in the Investigators' practices. No minors will be included in the study and it is anticipated that there will be a roughly equal representation of male and female subjects. Further, no subjects will be excluded because of race or ethnicity and all efforts will be made to adequately represent the study population in the area in which they are chosen. All subjects will be used for the analysis of efficacy and safety data.
Interventions
DEVICEInnovaMatrix AC porcine placental ECM therapy
All eligible subjects will be treated with a weekly application of sterilized, porcine placental ECM followed by standard of care moist wound therapy and offloading
Sponsors
ConvaTec Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Eligible subjects will be treated with a weekly application for 12 weeks of sterilized, porcine placental ECM followed by standard of care wound therapy and offloading
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female patients over 18 years of age who have given written informed consent in accordance with the ICH Good Clinical Practice (GCP) guideline. Female subjects must be either of non-childbearing potential or if of child bearing potential must satisfy the defined contraceptive criteria
Exclusion criteria
h. 2. Patients who are willing and able to attend all follow up visits 3. Subject has a known history of Type 1 or Type 2 diabetes with a HbA1c ≤12% . Has a diabetic foot ulcer classified by the Wagner classification 1 or 2 and at least 0.75cm2 and less than 5.0 cm2 in surface area as determined by photographic planimetry at the time of enrollment. 4. Index ulcer characteristics: 1. Ulcer present for ≥ 30 days prior to (Day 0) 2. Index ulcer is located below the ankle: at least 50% of the ulcer surface area is below the malleolus. 5. Subject has Body Mass Index (BMI) ≤ 45 at enrollment. 6. Subject has adequate circulation to the affected extremity, as demonstrated by at least one of the following within the past 30 days: * Dorsum transcutaneous oxygen test (TcPO2) with results ≥ 30 mmHg, Or * ABIs with results of ≥ 0.7 and ≤ 1.2, Or * Doppler arterial waveforms, which are triphasic or biphasic at the ankle of the affected foot. For ABPI \>1.2 TBI (Toe Brachial Index) \> 0.5. * Patient able to ambulate at home or in the clinic with or without mobility aids 8\. The subject is willing to accept treatment with a porcine based product 9. The subject is medically stable, in the opinion of the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing area using digital image | 12 weeks | The primary endpoint for the study is assessment of ulcer area at Weeks 6 and 12 using the MolecuLight Imaging Device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound Closure | 12 weeks | Time to complete wound closure as defined by FDA |
| Percentage area reduction | 12 weeks | • Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction |
| Adverse events | 12 weeks | Adverse events as reported at weekly treatment visits |
Other
| Measure | Time frame | Description |
|---|---|---|
| Presence of protease levels | 12 weeks | Reduction in host proteases at weeks 4,8, and 12. |
| Bacterial burden assessment | 12 weeks | Reduction in bacterial burden as assessed by fluorescence imaging using the moleculight imaging device at weeks 4, 8 and 12. |
Countries
United States
Outcome results
None listed