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Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

Primary Purpose

Foot Ulcer, Diabetic

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
DERMASEAL
Plasma Film
Standard of Care
Sponsored by
Vitruvian Medical Devices, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Foot Ulcer, Diabetic focused on measuring diabetes, non-healing, chronic, skin substitute

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Men or women ≥ 21 years of age.
  2. The subject is able and willing to adhere to study procedures and informed consent is obtained.
  3. 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.
  4. Target ulcer surface area between 1 - 10 cm2 after debridement with no active infection.
  5. Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per American Diabetes Association.)
  6. Additional wounds may be present but not within 2 cm of the target ulcer.
  7. 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)

  8. 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.
  9. HbA1c <10% taken within 30 days prior to Visit 3.
  10. Serum creatinine <3.0 mg/dl within the last 6 months.
  11. Willing and able (subject or responsible caregiver) to maintain required off-loading (as applicable for the location of the ulcer).
  12. 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.

Exclusion Criteria:

  1. 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)

  2. Patients presenting with an ulcer probing to tendon, capsule or bone (University of Texas Grade 2 or 3 or deep Wagner 2 or 3).
  3. Hypersensitivity to silver or fresh frozen plasma.
  4. The subject was previously entered into this study or had participated in any study drug or medical device study within 30 days of screening.
  5. 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).
  6. Excessive lymphedema that in the opinion of the investigator will interfere with wound healing.
  7. A cognitive, physical, or psychological condition interfering with subject's ability to comply with the treatment regimen.
  8. Active Charcot foot or unstable Charcot that in the opinion of the investigator will inhibit wound healing.
  9. 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.
  10. An ulcer that in the opinion of the investigator is not associated with the subject's diabetic neuropathic condition.
  11. Subjects is on dialysis.
  12. History of radiation to the target foot.
  13. Patients with uncontrolled autoimmune connective tissue diseases.
  14. Patients who are pregnant, breast feeding, or unwilling to practice contraceptive methods during participation in the study, if applicable. Effective methods of contraception include:

    i. oral, injectable, or implanted hormonal contraceptives ii. intrauterine device or system, iii. barrier method with spermicide, or iv. bilateral tubal occlusion.

  15. Patients with uncontrolled anemia (Hgb<10 g/dL in women; <12 g/dL in men) at Screening.
  16. Severe malnutrition (serum albumin ≤2.0 with a normal C-reactive protein).
  17. Wounds healed by >30% in area following the 2-week, active run-in period as measured during Visit 3.
  18. Use of hyperbaric oxygen, and active dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex, Dermagraft, Apligraf, etc.) within 30 days of study screening.
  19. Wounds >5 mm deep after sharp debridement.
  20. Clinical suspicion of skin cancer at or near the ulcer location which has not been ruled out by biopsy.

Sites / Locations

  • Limb Preservation Platform, Inc.Recruiting
  • Lower Extremity Institute for Research and Therapy, LLCRecruiting
  • Futuro Clinical Trials, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Standard of Care (SOC)

Plasma Film

DERMASEAL

Arm Description

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. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. Measure wound after debridement. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. Apply the Foot Defender® boot.

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. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. Measure wound after debridement. 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. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. Apply the Foot Defender® boot.

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. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. Measure wound after debridement. 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. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. Apply the Foot Defender® boot.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Wound healing
Percent of study wounds healed during the post-treatment weeks 1 through 4.
Complete wound closure
Time to complete wound closure.
Wound area change
Percent area change during the post-treatment weeks 2, 4, 6 and 16
Cost
Total indirect and direct costs of subject treatment during the study period

Full Information

First Posted
October 16, 2022
Last Updated
October 19, 2022
Sponsor
Vitruvian Medical Devices, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05586542
Brief Title
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
Official Title
A Double-Blind, Randomized, Placebo-Controlled, Multicenter Clinical Study to Assess the Safety of DERMASEAL Advanced Wound Care Dressing for the Treatment of Chronic Non-healing, Neuropathic Diabetic Foot Ulcers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vitruvian Medical Devices, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A double-blind, randomized, placebo-controlled, multi-center, phase 1 study to evaluate the safety of the DERMASEAL advanced wound care dressing in the treatment of non-healing diabetic foot ulcers located distal to the malleolus in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation. Subjects will be randomized in a 1:1:2 ratio to one of 3 treatment groups: SOC alone (n=6) SOC + plasma film (n=6) SOC + DERMASEAL (n=12) A subject's study duration will be up to a total of 18 weeks from screening to end of study. This includes a two-week active run-in followed by up to 4 weeks of treatment, plus a final follow-up visit 12 weeks after the last treatment. The primary endpoint is safety of topically applying a plasma film containing metallic silver microparticles plus fibrin in patients with chronic, non-healing neuropathic diabetic foot ulcers. Secondary endpoints to be assessed in each group include: Percent of study wounds healed during the post-treatment weeks 1 through 4, Time to complete wound closure, Percent area reduction during the post-treatment weeks 2, 4, 6 and 16, and Cost of treatment

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foot Ulcer, Diabetic
Keywords
diabetes, non-healing, chronic, skin substitute

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care (SOC)
Arm Type
Active Comparator
Arm Description
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. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. Measure wound after debridement. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. Apply the Foot Defender® boot.
Arm Title
Plasma Film
Arm Type
Experimental
Arm Description
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. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. Measure wound after debridement. 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. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. Apply the Foot Defender® boot.
Arm Title
DERMASEAL
Arm Type
Experimental
Arm Description
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. Wash the wound once more with saline to remove remaining debris and confirm hemostasis is achieved, as needed. Measure wound after debridement. 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. Place soft silicone contact layer dressing to cover over the wound, secured with adhesive strips. Cover the contact layer with a hydroconductive wound dressing secured with kerlix gauze and adhesive tape. Apply the Foot Defender® boot.
Intervention Type
Combination Product
Intervention Name(s)
DERMASEAL
Intervention Description
a novel skin substitute formulated as planar, thin film
Intervention Type
Biological
Intervention Name(s)
Plasma Film
Intervention Description
a planar, thin film made from human plasma
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
standard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment
Primary Outcome Measure Information:
Title
Adverse events
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Wound healing
Description
Percent of study wounds healed during the post-treatment weeks 1 through 4.
Time Frame
4 weeks
Title
Complete wound closure
Description
Time to complete wound closure.
Time Frame
16 weeks
Title
Wound area change
Description
Percent area change during the post-treatment weeks 2, 4, 6 and 16
Time Frame
16 weeks
Title
Cost
Description
Total indirect and direct costs of subject treatment during the study period
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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. Patients who are pregnant, breast feeding, or unwilling to practice contraceptive methods during participation in the study, if applicable. Effective methods of contraception include: i. oral, injectable, or implanted hormonal contraceptives ii. intrauterine device or system, iii. barrier method with spermicide, or iv. bilateral tubal occlusion. Patients with uncontrolled anemia (Hgb<10 g/dL in women; <12 g/dL in men) at Screening. Severe malnutrition (serum albumin ≤2.0 with a normal C-reactive protein). Wounds healed by >30% in area following the 2-week, active run-in period as measured during Visit 3. Use of hyperbaric oxygen, and active dressings that include growth factors, engineered tissues, or skin substitutes (e.g., Regranex, Dermagraft, Apligraf, etc.) within 30 days of study screening. Wounds >5 mm deep after sharp debridement. Clinical suspicion of skin cancer at or near the ulcer location which has not been ruled out by biopsy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hobart W Harris, MD, MPH
Phone
(415) 514-3891
Email
hobart.harris@ucsf.edu
Facility Information:
Facility Name
Limb Preservation Platform, Inc.
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Destiny Blackstone
Phone
559-431-1700
Email
destiny@llpresearch.com
First Name & Middle Initial & Last Name & Degree
Shawn Shawn, DPM
Facility Name
Lower Extremity Institute for Research and Therapy, LLC
City
Boardman
State/Province
Ohio
ZIP/Postal Code
44512
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maura DiDomenico
Phone
234-719-7588
Email
maura@leirt.com
First Name & Middle Initial & Last Name & Degree
David DiDomenico, DPM
Facility Name
Futuro Clinical Trials, LLC
City
McAllen
State/Province
Texas
ZIP/Postal Code
78501
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devla Archer
Phone
956-999-8399
Email
danayafct@gmail.com
First Name & Middle Initial & Last Name & Degree
Joseph M Caporusso, DPM

12. IPD Sharing Statement

Plan to Share IPD
No

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Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers

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