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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    24
  • sponsor
    Vitruvian Medical Devices, Inc.
Send
Updated on 23 October 2022
See if I qualify
diabetes
debridement
hysterectomy
follicle-stimulating hormone
hemoglobin a1c
healing ulcer

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.

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:

  1. Percent of study wounds healed during the post-treatment weeks 1 through 4,
  2. Time to complete wound closure,
  3. Percent area reduction during the post-treatment weeks 2, 4, 6 and 16, and
  4. Cost of treatment

Details
Condition Foot Ulcer, Diabetic
Treatment Standard of Care, DERMASEAL, Plasma Film
Clinical Study IdentifierNCT05586542
SponsorVitruvian Medical Devices, Inc.
Last Modified on23 October 2022

Eligibility

 Yes No Not Sure

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
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
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
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

diabetes
debridement
hysterectomy
follicle-stimulating hormone
hemoglobin a1c
healing ulcer

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note