Diabetes Clinical Trial
Official title:
An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers
Verified date | October 2019 |
Source | Mallinckrodt |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will occur with a minimum of one week between each subject.
Status | Completed |
Enrollment | 5 |
Est. completion date | May 28, 2019 |
Est. primary completion date | May 28, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
SUBJECT-SPECIFIC CRITERIA 1. Men and women 18 - 80 years of age, inclusive 2. Female subjects of childbearing potential must agree to practice birth control for the duration of the study 3. Documented Type 1 or Type 2 Diabetes Mellitus 4. HgbA1C = 10.0% 5. Ankle:brachial blood pressure index (ABI) of 0.7 to 1.3 - If ABI is > 1.3 (i.e., non-compressible ankle vessels) or cannot be measured, then Toe brachial index (TBI) of = 0.5, or - Doppler arterial waveforms that are triphasic or biphasic at the ankle of affected leg - If ABI and TBI cannot be measured, then Transcutaneous pressure (TcpO2) of = 40 around ulcer site, or - Skin perfusion pressure > 30 if neither ABI, TBI, nor TcpO2 can be measured near ulcer 6. Stable medications for 2 weeks prior to Study Treatment Day 0 - Sliding scale insulin permitted - Select antimicrobial therapies can be used as needed 7. Capable and willing to attend the scheduled visits and comply with study procedures 8. Signed informed consent form (ICF) for study enrollment WOUND-SPECIFIC CRITERIA 9. Full-thickness ulcer on the foot of 1.0 cm^2 - 5.0 cm^2 at Screening Visit after debridement with no clinical signs and symptoms of infection. Full thickness is defined as penetrating the dermis, but not extending beyond the subcutaneous tissue. 10. Study ulcer has been present for at least 4 weeks but not more than 1 year Exclusion criteria: MEDICAL HISTORY/CURRENT MEDICAL CONDITION 1. Pregnant or nursing women 2. Prisoners 3. Abnormal laboratory value(s) for routine blood work that the Clinical Investigator deems would not be in the subject's best interest to participate 4. Osteomyelitis in the study ulcer foot in the last 30 days 5. Grade 3 or 4 lower extremity edema 6. Unable to tolerate off-loading 7. Active Charcot's foot 8. History of malignancy in previous 5 years, except for basal cell carcinoma that has been treated with local excision and is no longer present 9. Patients with unstable chronic renal disease or requiring dialysis 10. Gangrene in any part of study ulcer foot 11. Patients with a history of above- or below-knee amputation in the contralateral leg related to underlying chronic disease. - History of toe amputation in either leg would not be exclusionary. 12. Patients with history of poor compliance 13. Patients with baseline panel reactive antibody (PRA) of = 20% MEDICATIONS/THERAPIES 14. Oral or parenteral corticosteroids, immunosuppressants, radiation therapy or chemotherapy within 30 days prior to study enrollment 15. Use of an investigational product within the preceding 60 days STUDY ULCER 16. Signs and symptoms of clinical infection at study ulcer site 17. Study ulcer requiring antimicrobial therapy at Screening Visit or Study Treatment Day 0 due to clinical suspicion of infection 18. Treatment of study ulcer with Regranex® or hyperbaric oxygen within preceding 30 days 19. Previous treatment of study ulcer with any cell and/or tissue product (CTP) therapy 20. Change in wound size (increase/decrease) greater than 25% from Screening Visit to Study Treatment Day 0 21. Other ulcers within 3 cm of study ulcer 22. Ulcers with tendon, muscle, joint capsule, or bone exposure |
Country | Name | City | State |
---|---|---|---|
United States | SerenaGroup Research Institute | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Stratatech, a Mallinckrodt Company | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events through study completion | Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events during the study. The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events through the 12 month study session. | Through study completion, at approximately 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05594446 -
Morphometric Study of the Legs and Feet of Diabetic Patients in Order to Collect Data Intended to be Used to Measure by Dynamometry the Pressures Exerted by Several Medical Compression Socks at the Level of the Forefoot
|
||
Completed |
NCT03975309 -
DHS MIND Metabolomics
|
||
Completed |
NCT01855399 -
Technologically Enhanced Coaching: A Program to Improve Diabetes Outcomes
|
N/A | |
Completed |
NCT01819129 -
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 Diabetes
|
Phase 3 | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Recruiting |
NCT05007990 -
Caregiving Networks Across Disease Context and the Life Course
|
||
Active, not recruiting |
NCT04420936 -
Pragmatic Research in Healthcare Settings to Improve Diabetes and Obesity Prevention and Care for Our Program
|
N/A | |
Recruiting |
NCT03549559 -
Imaging Histone Deacetylase in the Heart
|
N/A | |
Completed |
NCT04903496 -
Clinical Characteristics and Disease Burden of Diabetic Patients Based on Tianjin Regional Database
|
||
Completed |
NCT01437592 -
Investigating the Pharmacokinetic Properties of NN1250 in Healthy Chinese Subjects
|
Phase 1 | |
Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
Completed |
NCT03390179 -
Hyperglycemic Response and Steroid Administration After Surgery (DexGlySurgery)
|
||
Not yet recruiting |
NCT05029804 -
Effect of Walking Exercise Training on Adherence to Disease Management and Metabolic Control in Diabetes
|
N/A | |
Recruiting |
NCT05294822 -
Autologous Regenerative Islet Transplantation for Insulin-dependent Diabetes
|
N/A | |
Completed |
NCT04427982 -
Dance and Diabetes/Prediabetes Self-Management
|
N/A | |
Completed |
NCT02356848 -
STEP UP to Avert Amputation in Diabetes
|
N/A | |
Completed |
NCT03292185 -
A Trial to Investigate the Single Dose Pharmacokinetics of Insulin Degludec/Liraglutide Compared With Insulin Degludec and Liraglutide in Healthy Chinese Subjects
|
Phase 1 | |
Active, not recruiting |
NCT05477368 -
Examining the Feasibility of Prolonged Ketone Supplement Drink Consumption in Adults With Type 2 Diabetes
|
N/A | |
Completed |
NCT04496401 -
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
|
Phase 4 |