Foot Ulcer, DiabeticPhase 1NCT05586542
Study to Assess the Safety of DERMASEAL for Diabetic Foot Ulcers
A Phase 1 study testing DERMASEAL and Plasma Film in people with Foot Ulcer, Diabetic, run by Vitruvian Medical Devices, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Foot Ulcer, Diabetic
- What is being tested?
- DERMASEAL and Plasma Film
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Oct 2022to 30 Apr 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- 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.
Who cannot join
- Suspected or confirmed signs/symptoms of wound infection (subjects may be rescreened if the infection has been treated.) Infection is defined as, for example:
- 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).
- 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.
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- 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:
- 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.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Lower Extremity Institute for Research and Therapy, LLC
Boardman, Ohio, 44512
Limb Preservation Platform, Inc.
Fresno, California, 93710
Futuro Clinical Trials, LLC
McAllen, Texas, 78501
Doctors Research Network
South Miami, Florida, 33143
About this study
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
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.
Read the 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
- Conditions
- Foot Ulcer, Diabetic
- Being tested
- DERMASEAL, Plasma Film, Standard of Care
- Keywords
- diabetes, non-healing, chronic, skin substitute
- Medical subject headings
- Diabetic Foot, Diabetes Mellitus, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DERMASEALCombination product
a novel skin substitute formulated as planar, thin film
Plasma FilmBiological
a planar, thin film made from human plasma
Standard of CareOther
standard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Combination Product: DERMASEAL; Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (4)
Wound healing
Percent of study wounds healed during the post-treatment weeks 1 through 4.
Measured: 4 weeks
Complete wound closure
Time to complete wound closure.
Measured: 16 weeks
Wound area change
Percent area change during the post-treatment weeks 2, 4, 6 and 16
Measured: 16 weeks
Cost
Total indirect and direct costs of subject treatment during the study period
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start3 Oct 2022
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot Ulcer, DiabeticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vitruvian Medical Devices, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586542
- Sponsor's protocol ID
- VMD2022-001
- Status last verified
- Dec 2024
- First submitted
- 16 Oct 2022
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05586542
- Acronym / sponsor ID
- VMD2022-001
- Conditions
- Foot Ulcer, Diabetic
- Keywords
- diabetes, non-healing, chronic, skin substitute
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Vitruvian Medical Devices, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (SOC) | Active comparator | Other: Standard of Care1. 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. |
| Plasma Film | Experimental | Biological: Plasma Film, Other: Standard of Care1. 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. |
| DERMASEAL | Experimental | Combination Product: DERMASEAL, Other: Standard of Care1. 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.)
Key exclusion criteria (23 listed)
- Suspected or confirmed signs/symptoms of wound infection (subjects may be rescreened if the infection has been treated.) Infection is defined as, for example:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DERMASEALa novel skin substitute formulated as planar, thin film | Combination product | DERMASEAL |
| Plasma Filma planar, thin film made from human plasma | Biological | Plasma Film |
| Standard of Carestandard procedures for managing diabetic foot ulcers including debridement of unhealthy tissue and maintenance of a moist wound environment | Other | DERMASEAL, Plasma Film, Standard of Care (SOC) |
Primary outcome
Adverse events
Time frame: 16 weeks
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.
4 secondary outcomes
Wound healing
Time frame: 4 weeks
Complete wound closure
Time frame: 16 weeks
Wound area change
Time frame: 16 weeks
Cost
Time frame: 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DERMASEAL and Plasma Film in people with Foot Ulcer, Diabetic, run by Vitruvian Medical Devices, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.