Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

NCT05586542 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: VMD2022-001
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 4

Brief Summary

The goal of this clinical trial is to determine the safety of DERMASEAL for the treatment of non-healing, neuropathic diabetic foot ulcers. The main outcome measure is safety. A total of twenty-four (24) participants will be randomized to receive up to four (4) consecutive weeks of treatment with either standard of care (SOC), plasma film + SOC, or plasma film containing silver microparticles (DERMASEAL) + SOC, with a final follow-up visit 12 weeks after the last treatment.

Conditions

Foot Ulcer, Diabetic

Keywords

diabetes; non-healing; chronic; skin substitute

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Review of adverse events associated with the topical application of a plasma film containing metallic silver microparticles in patients with chronic non-healing neuropathic diabetic foot ulcers.

  16 weeks

Secondary Outcomes (4)

• Wound healing

  4 weeks

• Complete wound closure

  16 weeks

• Wound area change

  16 weeks

• Cost

  16 weeks

Study Arms (3)

Standard of Care (SOC)

ACTIVE COMPARATOR

1. Wash and sharps debride the target diabetic foot ulcer to remove all non-viable tissue, callus, epibole at wound edges, slough, and debris (at the physician's discretion). The wound margins should be excised to healthy bleeding tissue. 2. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. 3. Measure wound after debridement. 4. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. 5. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. 6. Apply the Foot Defender® boot.

Other: Standard of Care

Plasma Film

EXPERIMENTAL

1. Wash and sharps debride the target diabetic foot ulcer to remove all non-viable tissue, callus, epibole at wound edges, slough, and debris (at the physician's discretion). The wound margins should be excised to healthy bleeding tissue. 2. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. 3. Measure wound after debridement. 4. Place an appropriately sized piece of Plasma Film onto the wound bed. The test agent should be cut to fit the interior of the wound with minimal overlap onto healthy skin. 5. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. 6. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. 7. Apply the Foot Defender® boot.

Biological: Plasma Film; Other: Standard of Care

DERMASEAL

EXPERIMENTAL

1. Wash and sharps debride the target diabetic foot ulcer to remove all non-viable tissue, callus, epibole at wound edges, slough, and debris (at the physician's discretion). The wound margins should be excised to healthy bleeding tissue. 2. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. 3. Measure wound after debridement. 4. Place an appropriately sized piece of DERMASEAL onto the wound bed. The test agent should be cut to fit the interior of the wound with minimal overlap onto healthy skin. 5. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. 6. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. 7. Apply the Foot Defender® boot.

Combination Product: DERMASEAL; Other: Standard of Care

Interventions

DERMASEAL COMBINATION_PRODUCT

a novel skin substitute formulated as planar, thin film

DERMASEAL

Plasma Film BIOLOGICAL

a planar, thin film made from human plasma

Plasma Film

Standard of Care OTHER

standard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment

DERMASEAL; Plasma Film; Standard of Care (SOC)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men or women ≥ 21 years of age.
• The subject is able and willing to adhere to study procedures and informed consent is obtained.
• A non-healing ulcer that is diabetic and neuropathic in origin, located on the foot as defined by beginning \>50% below the malleoli of the ankle.
• Target ulcer surface area between 1 - 10 cm2 after debridement with no active infection.
• Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association.)
• Additional wounds may be present but not within 2 cm of the target ulcer.
• Patient has adequate arterial perfusion of the affected extremity as demonstrated by any one of the following within the past 90 days from the time of screening:
• i. Toe pressure (plethysmography) \>50 mm/Hg OR ii. Ankle Brachial Index (ABI) with results ≥ 0.70 and ≤ 1.2 OR iii. TcpO2 ≥30 mm Hg from the foot OR iv. Doppler arterial waveforms consistent with adequate flow in the foot (biphasic or triphasic waveforms at the ankle of affected leg)
• Target ulcer involves a full thickness skin loss, WITHOUT exposure of tendon, muscle, or bone (University of Texas Grade 1-A or Wagner Grade 1) that has been present ≥ 4 weeks. at the time of screening.
• HbA1c \<10% taken within 30 days prior to Visit 3.
• Serum creatinine \<3.0 mg/dl within the last 6 months.
• Willing and able (subject or responsible caregiver) to maintain required off-loading (as applicable for the location of the ulcer).
• Negative urine pregnancy test at Visit 3 for women of childbearing potential. i) Women participants are considered of non-childbearing potential if they are pre-menopausal with a documented hysterectomy or bilateral oophorectomy; or post-menopausal defined as the cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; or have a serum Follicle Stimulating Hormone level confirming the post-menopausal state.

You may not qualify if:

• Suspected or confirmed signs/symptoms of wound infection (subjects may be rescreened if the infection has been treated.) Infection is defined as, for example:
• i. purulence, erythema, cellulitis, excessively high temperatures in/around the ulcer, atypical smell, and/or excessive pain in/around the ulcer (infection may be treated and subject reconsidered for study participation).
• ii. osteomyelitis, with necrotic soft bone. (x-ray to be obtained if in the opinion of the investigator additional confirmation of diagnosis required)
• Patients presenting with an ulcer probing to tendon, capsule or bone (University of Texas Grade 2 or 3 or deep Wagner 2 or 3).
• Hypersensitivity to silver or fresh frozen plasma.
• The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
• Currently on a treatment regimen or medications which in the opinion of the investigator are known to interfere with wound healing (for example: cancer chemotherapy or equivalent immunosuppressants, systemic steroids \> 10 days of treatment, cytostatic drugs, cyclooxygenase-2 inhibitors, or radiation therapy).
• Excessive lymphedema that in the opinion of the investigator will interfere with wound healing.
• A cognitive, physical, or psychological condition interfering with subject's ability to comply with the treatment regimen.
• Active Charcot foot or unstable Charcot that in the opinion of the investigator will inhibit wound healing.
• Wounds secondary to vasculitis, neoplasms, or hematological disorders. Patients on anticoagulation medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center.
• An ulcer that in the opinion of the investigator is not associated with the subject's diabetic neuropathic condition.
• Subjects is on dialysis.
• History of radiation to the target foot.
• Patients with uncontrolled autoimmune connective tissue diseases.

Sponsors & Collaborators

• Vitruvian Medical Devices, Inc.: lead

Study Sites (4)

Limb Preservation Platform, Inc.

Fresno, California, 93710, United States

Location

Doctors Research Network

South Miami, Florida, 33143, United States

Location

Lower Extremity Institute for Research and Therapy, LLC

Boardman, Ohio, 44512, United States

Location

Futuro Clinical Trials, LLC

McAllen, Texas, 78501, United States

Location

MeSH Terms

Conditions

Diabetic Foot; Diabetes Mellitus; Bronchiolitis Obliterans Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Endocrine System Diseases; Diabetic Neuropathies; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: At each site, at least 1 staff member will be identified as the Unblinded Investigational Product Administrator. This site staff member will be responsible for all IP application and wound dressing and undressing at each study visit
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: October 3, 2022
• Primary Completion: March 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)