Diabetic Foot UlcerPhase 1/2NCT04755647
Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers
A Phase 1/2 study testing Nitric Oxide-Releasing Solution and Saline solution, hypotonic in people with Diabetic Foot Ulcer, run by Sanotize Research and Development corp. at 1 site in Canada.
Trial summary
The purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- Nitric Oxide-Releasing Solution and Saline solution, hypotonic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 23 Feb 2021to 20 May 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-hospitalized, ambulatory patients with controlled diabetes mellitus as determined by physician diagnosis recorded in the medical record. Diabetes may be treated with insulin, oral hypoglycemic agents or diet alone. Patient glycaemic control (HbA1c) should be less than or equal to 12 % within 2 weeks of enrollment;
- Must be ≥ 19 years of age unless local laws dictate otherwise;
- Participants must be considered reliable, willing and able to give signed informed consent, and sign the informed consent form.
- Participant is willing to be randomized and able to comply with the protocol
- Participants must have either:
- 1 or more full thickness ulcers on the foot below the malleoli with a surface area exceeding 0.5 cm2 (50 mm2) after debridement (full thickness means extending through the epidermis and dermis but not involving tendon, bone, or joint capsule); or ii) 1 or more partial thickness ulcers (i.e., do not completely penetrate the dermis) of forefoot or digits; or iii) 1 or more ulcers of the forefoot or digits have granulation tissue at their base.
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- Participants must have localized mild infection of at least 1 ulcer that would ordinarily be treated on an outpatient basis. Mild infection of an ulcer is defined by the presence of at least 2 manifestations of inflammation (purulence, erythema, pain, tenderness, warmth, or induration) which is limited to the skin or superficial subcutaneous tissues. If there is more than one ulcer meeting eligibility, the Investigator will determine which ulcer will be followed for the course of the study.
- Mild infection defined by IDSA criteria34:
- "Local infection involving only the skin and the subcutaneous tissue (without involvement of deeper tissues and without systemic signs as described below).
- If erythema, must be >0.5 cm to ≤2 cm around the ulcer. Exclude other causes of an inflammatory response of the skin (e.g., trauma, gout, acute Charcot neuro-osteoarthropathy, fracture, thrombosis, venous stasis)."
- Participants who have been previously treated or are currently under treatment for a localized infection of an ulcer may be enrolled if there has been an inadequate response to treatment and the ulcer is still infected as described above.
- Participants must have a radiograph (appropriate views as determined by the investigator) within the 2 weeks prior to entry showing no evidence of cortical destruction consistent with osteomyelitis in the affected foot.
- Participants must have either:
- A palpable dorsalis pedis or posterior tibial pulse in the affected foot; or ii) If the pulse is congenitally absent or not palpable due to edema, a Dopplerable dorsalis pedis or posterior tibial pulse measured at ≥ 30 mm Hg; or iii) If there are no palpable pulses, non Dopplerable pulses, rest pain, or claudication on walking less than one block are present, the patient may be enrolled only if a vascular surgeon has determined that vascular surgery, angioplasty or amputation is not warranted.
- Participants must have no more than a reduced wound area of ≤30% documented by the PI, during the 2 weeks of screening, in which patients received institutional standard of care (SOC)
- Participants may not be taking or have received any other investigational therapy or approved therapy (i.e., drug or device) for investigational use within the 30 days prior to entry.
- Female Participants must be postmenopausal for at least 6 months; surgically sterilized (hysterectomy or tubal ligation); or, if of child-bearing potential, must have a negative pregnancy test prior to entry and must be willing to use one highly effective birth control method which include: hormonal contraceptives (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy and tubal ligation or to use two forms of effective birth control methods which include: barrier methods of contraception (e.g. male condom, female condom, cervical cap, diaphragm, contraceptive sponge). The Participants must have used the birth control method for at least 2 complete menstrual cycles prior to study entry.
Who cannot join
- Participants with limb threatening infection, extensive cellulitis (≥2 cm beyond the ulcer), lymphangitis, fasciitis, deep tissue infection, an abscess, or other evidence of local complications of infection.
- Participants with symptoms of systemic infection (e.g., severe hyperglycemia, ketoacidosis, azotemia).
- Participants requiring concurrent local or systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
- Participants who are currently treated by dialysis, awaiting dialysis or who have an estimated glomerular filtration rate of ≤20 mL/min/173 m2.
- Participants who are expected to be unable to care for their ulcer because of hospitalization, vacation, disability, etc. during the study period.
- Participants with known active alcohol or substance abuse within the 6 months preceding study entry.
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- Participants who are receiving systemic corticosteroids (in a dose equivalent to ≥ 20 mg of prednisone per day) immunosuppressive radiation therapy, or cytotoxic agents
- Participants who require treatment for a primary or metastatic malignancy (other than squamous or basal cell carcinoma of the skin).
- Participants with a systemically immunocompromising disease, such as acquired immune deficiency syndrome or known human immunodeficiency virus (HIV) positivity.
- Participants who have an unexplained fever or chills during the week prior to enrollment.
- Participants with other conditions considered by the investigator to be reasons for disqualification that may jeopardize patient safety or interfere with the objectives of the trial (e.g., acute illness or exacerbation of chronic illness, lack of motivation, history of poor compliance).
- Women who are breast feeding, pregnant or attempting to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety & Efficacy of Topical Nitric Oxide Releasing Solution (NORS) Delivered as an Adjunctive Footbath Treatment as Compared to Placebo in the Management of Diabetic Foot Ulcers
The purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.
Read the detailed description
It is hypothesized that a single, relatively short exposure (three times a week for a half hour) of a nitric oxide releasing solution (NORS) for four (4) week period will be well tolerated and may have other beneficial secondary outcomes for individuals presenting with diabetic foot ulcers.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- Nitric Oxide-Releasing Solution, Saline solution, hypotonic
- Keywords
- nitric oxide, diabetic wounds, diabetic foot ulcer, drug resistent wound
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitric Oxide-Releasing SolutionDrug
Active antimicrobial
Saline solution, hypotonicDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Nitric Oxide-Releasing Solution (NORS) | Experimental | Five litre foot bath delivery NORS Receives: Drug: Nitric Oxide-Releasing Solution |
| Saline | Placebo comparator | Five litre foot bath delivery NORS Receives: Drug: Saline solution, hypotonic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the number of participants discontinued or lost to follow-up in the NORS compared to hypotonic saline in participants with diabetic foot ulcers (DFU)
Proportion of participants lost-to-follow-up, discontinuing study treatment due to intolerance or adverse events, or initiating new medications or treatments, or leaving/discontinuing the study for any other reason
Measured: 28 days
To measure the severity of adverse events of NORS compared to hypotonic saline in participants with DFU
Severity as measured by adverse event scale (1-5) and frequency of adverse events that results in discontinuation of the investigative treatment.
Measured: 29 days
To measure the negative changes in laboratory values of NORS compared to hypotonic saline with DFU
Proportion of negative laboratory changes resulting in discontinuation of investigative treatments.
Measured: 29 days
To measure the negative changes in vital sign during NORS compared to hypotonic saline administration in participants with DFU
Proportion of subjects with deterioration in vital signs resulting in discontinuation of investigative treatment.
Measured: 29 days
To measure worsening of wound infection during NORS compared to hypotonic saline administration in participants with DFU
Proportion of subjects with incidence of infection resulting in discontinuation of the investigative treatment.
Measured: 29 days
To measure worsening of wound area during NORS compared to hypotonic saline administration in participants with DFU
Proportion of subjects with increased wound area resulting in discontinuation of the investigative treatment.
Measured: 29 days
To measure the methemoglobin percent level during NORS compared to hypotonic saline administration in participants withe DFU
Proportion of subjects with an increase in methemoglobin percent level resulting in discontinuation of the investigative treatment.
Measured: 29 days
Secondary outcomes (5)
To measure the efficacy of NORS compared to placebo on the change in pathogen load in participants with DFU
Mean change in pathogen density as measured by colony forming units per milliliter (cfu/mL) compared to control
Measured: 29 days
To measure the efficacy of NORS compared to placebo on the change in bacterial load (CFU/mL) in participants with DFU
Proportion of participants with a reduction in bacterial load as compared to control
Measured: 29 days
To measure the efficacy of NORS compared to placebo on the reduction of the number of clinical signs of infection in participants with diabetic foot ulcers (DFU)
Proportion of participants with Clinical Response defined as resolution of one or more clinical signs of infection reported compared to control
Measured: 29 days
To measure the efficacy of NORS compared to placebo on the change in wound bacterial microbiota (species) in participants with DFU
Mean changes in percentage of bacterial microbiota (species) will be determined by comparing to control
Measured: 29 days
To measure the efficacy of NORS compared to placebo on the change in wound area in participants with DFU
Mean % change in wound area calculated for DFU compared to control
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start23 Feb 2021
- Primary completion20 May 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Foot UlcerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a single-center, randomized, placebo controlled parallel group,clinical safety study comparing an investigational drug add-on to a placebo control. Up to 40 participants with mildly infected neuropathic or non-neuropathic or neuro-ischemic diabetic foot ulcers will be enrolled.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanotize Research and Development corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Schumacher, MD, Principal investigator, Achilles Foot Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755647
- Sponsor's protocol ID
- DFU-CTP-01
- Status last verified
- Oct 2022
- First submitted
- 8 Feb 2021
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of Topical Nitric Oxide Releasing Solution (NORS) Delivered as an Adjunctive Footbath Treatment as Compared to Placebo in the Management of Diabetic Foot Ulcers
- ClinicalTrials.gov ID
- NCT04755647
- Acronym / sponsor ID
- DFU-CTP-01
- Conditions
- Diabetic Foot Ulcer
- Keywords
- nitric oxide, diabetic wounds, diabetic foot ulcer, drug resistent wound
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sanotize Research and Development corp.Industry (pharma, biotech, devices)
- Study start
- 23 Feb 2021 (actual)
- Primary completion
- 20 May 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 16 Feb 2021 (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 purpose of this study is to investigate the safety and effectiveness of a nitric oxide releasing solution, delivered as a footbath, to act as an antimicrobial treatment for participants presenting with a diabetic foot ulcer.
Detailed description
It is hypothesized that a single, relatively short exposure (three times a week for a half hour) of a nitric oxide releasing solution (NORS) for four (4) week period will be well tolerated and may have other beneficial secondary outcomes for individuals presenting with diabetic foot ulcers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a single-center, randomized, placebo controlled parallel group,clinical safety study comparing an investigational drug add-on to a placebo control. Up to 40 participants with mildly infected neuropathic or non-neuropathic or neuro-ischemic diabetic foot ulcers will be enrolled.
| Arm | Type | Receives |
|---|---|---|
| Nitric Oxide-Releasing Solution (NORS) | Experimental | Drug: Nitric Oxide-Releasing SolutionFive litre foot bath delivery NORS |
| Saline | Placebo comparator | Drug: Saline solution, hypotonicFive litre foot bath delivery NORS |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Non-hospitalized, ambulatory patients with controlled diabetes mellitus as determined by physician diagnosis recorded in the medical record. Diabetes may be treated with insulin, oral hypoglycemic agents or diet alone. Patient glycaemic control (HbA1c) should be less than or equal to 12 % within 2 weeks of enrollment;
- Must be ≥ 19 years of age unless local laws dictate otherwise;
- Participants must be considered reliable, willing and able to give signed informed consent, and sign the informed consent form.
- Participant is willing to be randomized and able to comply with the protocol
- Participants must have either:
Key exclusion criteria (12 listed)
- Participants with limb threatening infection, extensive cellulitis (≥2 cm beyond the ulcer), lymphangitis, fasciitis, deep tissue infection, an abscess, or other evidence of local complications of infection.
- Participants with symptoms of systemic infection (e.g., severe hyperglycemia, ketoacidosis, azotemia).
- Participants requiring concurrent local or systemic antimicrobials during the study period for any infection, including diabetic foot ulcer.
- Participants who are currently treated by dialysis, awaiting dialysis or who have an estimated glomerular filtration rate of ≤20 mL/min/173 m2.
- Participants who are expected to be unable to care for their ulcer because of hospitalization, vacation, disability, etc. during the study period.
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 |
|---|---|---|
| Nitric Oxide-Releasing SolutionActive antimicrobial | Drug | Nitric Oxide-Releasing Solution (NORS) |
| Saline solution, hypotonicPlacebo | Drug | Saline |
Primary outcome
To measure the number of participants discontinued or lost to follow-up in the NORS compared to hypotonic saline in participants with diabetic foot ulcers (DFU)
Time frame: 28 days
Proportion of participants lost-to-follow-up, discontinuing study treatment due to intolerance or adverse events, or initiating new medications or treatments, or leaving/discontinuing the study for any other reason
To measure the severity of adverse events of NORS compared to hypotonic saline in participants with DFU
Time frame: 29 days
Severity as measured by adverse event scale (1-5) and frequency of adverse events that results in discontinuation of the investigative treatment.
To measure the negative changes in laboratory values of NORS compared to hypotonic saline with DFU
Time frame: 29 days
Proportion of negative laboratory changes resulting in discontinuation of investigative treatments.
To measure the negative changes in vital sign during NORS compared to hypotonic saline administration in participants with DFU
Time frame: 29 days
Proportion of subjects with deterioration in vital signs resulting in discontinuation of investigative treatment.
To measure worsening of wound infection during NORS compared to hypotonic saline administration in participants with DFU
Time frame: 29 days
Proportion of subjects with incidence of infection resulting in discontinuation of the investigative treatment.
To measure worsening of wound area during NORS compared to hypotonic saline administration in participants with DFU
Time frame: 29 days
Proportion of subjects with increased wound area resulting in discontinuation of the investigative treatment.
To measure the methemoglobin percent level during NORS compared to hypotonic saline administration in participants withe DFU
Time frame: 29 days
Proportion of subjects with an increase in methemoglobin percent level resulting in discontinuation of the investigative treatment.
5 secondary outcomes
To measure the efficacy of NORS compared to placebo on the change in pathogen load in participants with DFU
Time frame: 29 days
To measure the efficacy of NORS compared to placebo on the change in bacterial load (CFU/mL) in participants with DFU
Time frame: 29 days
To measure the efficacy of NORS compared to placebo on the reduction of the number of clinical signs of infection in participants with diabetic foot ulcers (DFU)
Time frame: 29 days
To measure the efficacy of NORS compared to placebo on the change in wound bacterial microbiota (species) in participants with DFU
Time frame: 29 days
To measure the efficacy of NORS compared to placebo on the change in wound area in participants with DFU
Time frame: 29 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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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.
Scott Schumacher, MD principal investigator
Achilles Foot Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nitric Oxide-Releasing Solution and Saline solution, hypotonic in people with Diabetic Foot Ulcer, run by Sanotize Research and Development corp. at 1 site in Canada.
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 17 inclusion and 12 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: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure the number of participants discontinued or lost to follow-up in the NORS compared to hypotonic saline in participants with diabetic foot ulcers (DFU) (time frame: 28 days). The study lists 7 primary outcomes in all. 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 31 May 2023.