Wound Heal Clinical Trial
Official title:
A Prospective, Multi Center Observational Study to Investigate the Safety and Effectiveness of Sterilized, Porcine Placental Tissue in the Treatment of Chronic Venous Leg Ulcers
NCT number | NCT06400875 |
Other study ID # | TLS-IM-002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | July 10, 2023 |
Est. completion date | February 8, 2024 |
Verified date | May 2024 |
Source | ConvaTec Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study is a multi-center, prospective, clinical trial designed to evaluate the use of InnovaMatrix AC sterilized porcine placental ECM to treat chronic VLUs . The trial will include 30 completed subjects at multiple, experienced clinical centers in the United States.
Status | Completed |
Enrollment | 37 |
Est. completion date | February 8, 2024 |
Est. primary completion date | February 8, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 childbearing potential must satisfy the defined contraceptive criteria Exclusion criteria. 2. Patients who are willing and able to attend all follow-up visits. 3. Index ulcer characteristics: 1. Ulcer present for = 30 days prior to (Day 0). 2. Index ulcer is above the malleolus. 3. Ulcer greater than or equal to 2cm2 and less than or equal to 20cm2 at the time of enrollment. 4. 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. 5. The subject is willing to accept treatment with a porcine based product and to undergo weekly compression wrapping. 6. The subject is medically stable, in the opinion of the investigator. Exclusion Criteria: Potential subjects meeting any of the following criteria will be excluded from enrollment 1. Index Ulcer Assessment: 1. Penetrates down to muscle, tendon, or bone. 2. Presence of another venous leg ulcer within 2 cm of the index ulcer 3. Index ulcer determined to be due to a condition other than venous insufficiency. 4. Exhibits overt clinical signs and symptoms of infection with cellulitis surrounding the wound margin. 5. Known or suspected local skin malignancy to the index diabetic ulcer. 6. Wound duration > one year without intermittent closure. 2. Prior therapies - Subjects receiving treatment with any of the following will not be eligible for enrollment: 1. In the last 7 days - Negative pressure wound therapy (wound vac or SNaPĀ®) of the index ulcer 2. In the last 7 days - Hyperbaric oxygen (HBO) therapy 3. In the last 30 days - Treatment with cytotoxic chemotherapy, application of topical steroids to the ulcer surface, or use of = 14 days of immune-suppressants (including systemic corticosteroids); or subject is anticipated to require such medications during the course of the study 4. In the last 30 days - study ulcer treatment with any advanced therapy, including, biomedical or topical growth factors, tissue engineered materials (e.g. Apligraf or Dermagraft), sterilized placental allografts (EpiFix, NovaFix, etc.), or other scaffold materials (e.g. OASISĀ® Wound Matrix, MatriStem Wound Matrix ) 5. In the last 8 weeks - Amputation or revascularization (surgical or stenting) to the affected leg 3. Subject criteria that will make subject ineligible for enrollment: 1. Known hypersensitivity to porcine based products. 2. Known osteomyelitis or active cellulitis requiring antimicrobial therapy at wound site. 3. End stage renal disease requiring dialysis. 4. Immune system disorders including Systemic Lupus Erythematosus (SLE), Acquired Immunodeficiency Syndrome (AIDS) or HIV 5. Presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the Investigator. 6. Pregnancy at enrollment or women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence). 7. Subjects currently enrolled in this study. Concurrent enrollment in the study is prohibited. 8. Subjects currently receiving radiation therapy or chemotherapy. 9. Any pathology that would limit the blood supply and compromise healing or non-revascularizable surgical sites |
Country | Name | City | State |
---|---|---|---|
United States | The Serena Group | Cambridge | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
ConvaTec Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Patient compliance with recommendations | Patient compliance with behavioral treatment recommendations for the healing of venous leg ulceration. Treatment recomendations defined as multilayer compression therapy (as supplied by SerenaGroupĀ®), with weekly assessments of effectiveness of multilayer compression with patient compliance. | 12 Weeks | |
Other | App Usability | Assess ease of device using SUS questionnaire for WoundAlert smartphone application. To be completed by subject and provider
The SUS scoring rule is as follows: (1) based on the level, each problem has a base score that ranges from 1-5, which corresponds to the range from "strongly disagree" to "strongly agree"; (2) the scores for questions 1, 3, 5, 7, and 9 are equal to the base score minus 1; the scores for questions 2, 4, 6, 8, and 10 are equal to five minus the base score; (3) the scores of the ten questions are added to obtain the total score of the questionnaire; and the questionnaire SUS score is the total score times 2.5. The SUS is represented as a percentage. |
End of Study | |
Other | Bacterial Burden | Reduction in bacterial burden as assessed by fluorescence imaging and polymerase chain reaction (PCR). | 12 Weeks | |
Primary | Wound Area | Assessment of ulcer area (percent area reduction from baseline) | 12 Weeks | |
Secondary | Time to complete wound closure | Time to complete wound closure as defined by FDA. | 12 Weeks | |
Secondary | Rate of wound closure | Rate of wound closure as assessed by wound area measurements determined by weekly percent area reduction. | 12 Weeks | |
Secondary | Adverse Events | Incidence of adverse events | 12 Weeks | |
Secondary | Reduction in pain | Assessment of the pain level linked to the wound, using the validated PEG pain scale (0-10), with a higher score indicating more severe pain and pain-related interference with life and activities. | 12 Weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05023135 -
DeepView SnapShot Portable (DV-SSP): Device Training Study
|
||
Recruiting |
NCT03459547 -
Soft Peri-implant Tissue Around Different Abutment Materials
|
N/A | |
Recruiting |
NCT05608187 -
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
Active, not recruiting |
NCT03649308 -
Negative Pressure Wound Therapy Compared to Traditional Care After Skin Grafting
|
N/A | |
Recruiting |
NCT04596124 -
Effectiveness and Tolerability of Fitostimoline Plus Cream and Gauze vs Connettivina Bio Plus Cream and Gauze
|
N/A | |
Completed |
NCT03285542 -
Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty
|
N/A | |
Recruiting |
NCT05474911 -
PILONIDAL SINUS: CONVENTIONAL CARE VERSUS NEGATIVE PRESSURE THERAPY.
|
N/A | |
Recruiting |
NCT05689775 -
Reconstruction After Abdominoperineal Resection With Robot-assisted Harvest of VRAM Flap
|
||
Recruiting |
NCT04849143 -
The Effectiveness of Stingless Bee Honey (Kelulut Honey) Versus Gel in Diabetic Wound Bed Preparation
|
N/A | |
Completed |
NCT03596112 -
The Difference in Wound Size Reduction Comparing Two Frequently Used Wound Dressings in Everyday Care
|
N/A | |
Recruiting |
NCT05169814 -
Micro/Nanobubbles (MNBs) for Treatment of Acute and Chronic Wounds
|
Early Phase 1 | |
Completed |
NCT04545476 -
Enhanced Secondary Intention Healing vs. Standard Secondary Intention Healing in Mohs Surgical Defects on the Head and Distal Lower Extremities
|
N/A | |
Completed |
NCT06020157 -
Comparison of Simple and Continuous Suture Techniques in Oral Surgery
|
N/A | |
Recruiting |
NCT05133570 -
Study Evaluating the Effectiveness of Treatment With Vista Care®, in Arterial Ulcers of the Lower Extremities
|
||
Recruiting |
NCT04901325 -
Baricitinib in the Treatment of Adults With Pyoderma Gangrenosum (PG)
|
Phase 2 | |
Withdrawn |
NCT03668665 -
Influencing Wound Healing Through the Application of Hyaluronic Acid With Perfluorodecalin and Physalis Angulata Extract After Split Skin Removal From the Thigh - A Study in "Split Wound Design"
|
Phase 3 | |
Completed |
NCT03703479 -
Effect of A-PRF After Removal of Wisdom Teeth
|
N/A | |
Recruiting |
NCT03204851 -
Microlyte Dressing in the Management of Wounds
|
N/A | |
Recruiting |
NCT06117436 -
Impact of Cilostazol Versus Cilostazol and Selenium Combination on the Healing of Diabetic Foot Ulcer Patients
|
Phase 2/Phase 3 | |
Completed |
NCT05618912 -
Scar Appearance After Postoperative Hydrocolloid Dressing Versus Standard Petrolatum Ointment
|
N/A |