Diabetic Foot Ulcer (DFU)
Conditions
Keywords
Diabetes, Diabetic Foot, Allograft, Scaffold, Wound Healing, Advanced Wound Care, Comparative Effectiveness, Lower Extremity Ulcer, Time to heal, Treatment, Diabetes Complication, Skin Ulcer, Neuropathy, Peripheral artery disease, Ischemia, Wagner Grade
Brief summary
The goal of this clinical trial is to learn if using FoundationDRS Solo improves healing of chronic, non-healing foot ulcers in diabetic patients. The main question that this study aims to answer is: Does FoundationDRS Solo, when used in conjunction with standard of care wound management techniques, result in a higher percentage of target ulcers achieving complete closure (i.e. healing) as compared to ulcers being treated with standard of care alone after 12 weeks of treatment. One ulcer on each participant's foot will receive weekly applications of 1) FoundationDRS Solo and standard of care wound management or 2) standard of care wound management alone. Pictures of the ulcer and measurements of its size will be measured every week to track its healing progress over a total treatment period of 12 weeks. Additionally, the participants will be asked to fill out a questionnaire about the wound impacts their life and their quality of life.
Detailed description
Patients with diabetes often develop ulcers on their lower extremities. While some ulcers can be managed using standard of care wound management techniques including debridement, moist dressings, infection control and off-loading, many develop into chronic, non-healing wounds. Chronic non-healing wounds can lead to higher risk of infection, amputation and decreased quality of life. Advanced wound therapies aim to promote rapid and complete healing of chronic wounds. Examples of an advanced wound therapies include scaffolds that contain and / or mimic the structure and function of the natural extracellular matrix of tissue. Several biomimetic scaffolds have been cleared for the management of a variety of wounds (including DFU's) by the US FDA. The focus of this clinical trial is to determine the clinical utility of treating diabetic foot ulcers with weekly applications of FoundationDRS Solo in addition to standard of care wound management techniques compared to applying standard of care wound management only. It is hypothesized that the addition of FoundationDRS Solo to standard of care treatment will result in a higher percentage of ulcers achieving complete closure (i.e. healing) compared to ulcer being treated with standard of care alone after 12 weeks of treatment. To test this hypothesis the study will consist of patients who will undergo standard of care for 4-weeks prior to entering a 12-week treatment phase. During the 4-week standard of care phase, patients meeting inclusion criteria (including confirmation that ulcer does not reduce in area by more than 50%) will be randomized into the treatment groups. During the 12-week treatment phase, index wounds will be treated weekly with FoundationDRS Solo and standard of care or standard of care alone. Evaluation of data (outcome measures) associated with the trial will include intent to treat and per protocol analyses which will be performed by at least one blinded statistician and investigator.
Interventions
OTHERFoundationDRS Solo
FoundationDRS Solo is a porous, degradable composite scaffold composed of chitosan and chondroitin sulfate
OTHERStandard of Care
Standard of care (SOC) will include cleansing of the index wound with sterile normal saline solution, followed by sharp debridement to remove necrotic tissue, application of appropriate dressings and wound off-loading
Sponsors
Samaritan Biologics
Emergent Clinical Consulting, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study will be a multicenter, prospective, randomized design in which one treatment group will be compared to one control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 1\. Subjects must be at least 18 years of age or older. 2. Subjects must have a diagnosis of type 1 or 2 Diabetes mellitus requiring treatment with oral medications and/or insulin replacement therapy. 3. At randomization subjects must have a target ulcer with a minimum surface area of 1.0 cm2 and a maximum surface area of 20.0 cm2 measured post debridement prior to randomization at treatment visit 1 (TV1). 4. The target ulcer must have been present for a minimum of 4 weeks and is unresponsive (defined by less than 50% wound area reduction) to standard wound care. 5. The target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus. 6. The target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below either malleoli. 7. The affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the first screening visit are acceptable: 1. ABI between 0.7 and ≤ 1.3; 2. TBI ≥ 0.6; 3. TCOM ≥ 40 mmHg; 4. PVR: biphasic; 5. skin perfusion pressure (SPP) ≥ 30 mmHg. 8. If the subject has two or more ulcers, they must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
Exclusion criteria
will be designated as the target ulcer. 9. The index ulcer has been offloaded with protocol defined offloading device for at least 14 days prior to randomization (i.e. Screening through TV1/Randomization). 10. The potential subject must consent to using the prescribed offloading method for the duration of the study. 11. The potential subject must agree to attend the weekly study visits required by the protocol. 12. The potential subject must be willing and able to participate in the informed consent process. 13. Index ulcer and/or index ulcer limb may have had prior infection(s), but must be adequately treated and controlled as defined by IDSA Guidelines Grade level 1 (Appendix L). 14. The index ulcer has a clean base and is free from necrotic debris at time of placement of product / treatment. 15. Negative pregnancy test for females of childbearing potential (e.g., not post-menopausal for at least one yar or surgically sterile). Females of childbearing potential must be willing to use acceptable methods of contraception (birth control pills, barriers, or abstinence) starting at Screening and continuing through the duration of their study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Complete Wound Closure | 12-weeks following study screening phase | The percentage of wounds completely healed. Complete healing will be defined as 100% epithelialization without drainage and need for dressing or wound size ≤ 0.1cm\^2 as determined by the site investigator and validated by a blinded review board. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to wound closure | 12-weeks following study screening phase | Time to wound closure over 12 weeks will be determined via a Kaplan-Meier analysis |
| Percent reduction in wound area | 12-weeks following study screening phase | Percent reduction of wound area \[(Ai-Axw\]) / Ai\] x100, where Ai is the area of the index wound at randomization, Axw is the wound area at weekly intervals. |
| Adverse Events | 12-weeks following study screening phase | A symptom, sign, illness or experience that develops or worsens in severity during the course of the study. Intercurrent illnesses or injuries will be regarded as adverse events. Abnormal results of laboratory or diagnostic procedures are considered to be adverse events if the abnormality: Leads to study withdrawal. Is associated with a serious adverse event. Is associated with clinical signs or symptoms. Leads to additional treatment or to further diagnostic tests. Is considered by the Investigator to be of clinical significance |
| Wound Quality of life (Wound-QoL) questionnaire | 12-weeks following study screening phase | Average scores will range from 0 (lowest score) to 4 (highest score), with a higher score indicating that the wound effected the subject's quality of life more severely. |
Countries
United States
Contacts
CONTACTJeremy J Mercuri, PhD
CONTACTJerry Chang, BS
Outcome results
None listed