Diabetic Foot UlcerEarly Phase 1NCT05076955
Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation Therapy
A Early Phase 1 study testing vancomycin-tobramycin-itraconazole in people with Diabetic Foot Ulcer, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
Diabetic foot ulcers (DFUs) are a frequent clinical problem observed in diabetic patients. Properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnostic and therapeutic approaches. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Foot Ulcer
- What is being tested?
- vancomycin-tobramycin-itraconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2021to Dec 2022
- Phase
- Early Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 or Type 2 diabetes mellitus
- An open DFU / wound of any size (including those requiring debridement in operation room or clinic setting) with or without a secondary fungal infection
- ≥ 18 years of age
- Treatment naïve or treatment failure with oral antibiotics to current wound infection
Who cannot join
- Patients who present with untreated or on active-treatment for osteomyelitis, exposed bone, or have a life-threatening need of immediate surgery.
- Patients who are allergic to any components of the investigated product.
- Patients who have ≥ 15 shoe size
- Patients who have received IV antibiotics within the past 30 days
- Patients with HgbA1C > 14
- Patients on active cancer treatment
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- Patients needing re-vascularization of the affected area but did not receive treatment.
- Patients diagnosed with HIV/AIDs
- Patients unable or unwilling to obtain and wear off-loading footwear
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Laura R Vick, MD, 601-278-6213, lvick@umc.edu
Kirby Orme, MD, 601-984-5080, korme@umc.edu
About this study
Official title: Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation
Diabetic foot ulcers (DFUs) are a frequent clinical problem observed in diabetic patients. Properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnostic and therapeutic approaches. The purpose of this study is to evaluate the effectiveness of a compounded, anti-infective irrigation therapy to increase the healing rates of diabetic foot ulcers and thereby provide a new therapeutic option for health care providers treating high-risk patients with DFUs regardless if secondary fungal infections are present.
Participants diagnosed with diabetes type 1 or 2 and with a documented open diabetic foot ulcer/wound with or without a secondary fungal infection will be included in this prospective, active intervention pilot study. Healing rates will be evaluated every two weeks following the initiation of study therapy up to three months. Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. Participants will be asked to return to clinic every two - four weeks for assessment of the ulcer and compliance with treatment.
A sample size of approximately 100 patients is estimated to have 90% power to detect 15% improvement in ulcer healing rates to 45% and 35% compared to historical benchmarks of approximately 30% for ulcers of <6 months duration and 20% for ulcers ≥6 months duration and/or prior treatment failure, respectively.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- vancomycin-tobramycin-itraconazole
- Medical subject headings
- Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin-tobramycin-itraconazoleDrug
Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. This is an irrigating foot bath with a compounded medication of vancomycin-tobramycin-itraconazole. This medication with combined 3/4 gallon of water. Participant will soak foot in solution for 10 minutes per day. Daily until wound is healed for a minimum of 4 weeks and a maximum of 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Treatment of Diabetic Foot Ulcer | Experimental | Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. This is an irrigating foot bath with a compounded medication of vancomycin-tobramycin-itraconazole. This medication with combined 3/4 gallon of water. Participant will soak foot in solution for 10 minutes per day. Daily until wound is healed for a minimum of 4 weeks and a maximum of 3 months. Receives: Drug: vancomycin-tobramycin-itraconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing Rate
We will be looking at measurements of the wound at the start of the study and at each study visit until the wound is healed, or the study has ended. The wounds are measured with a ruler by the provider seeing the patient at the time of the visit in centimeters. The wounds are also photographed with a ruler in the photograph for size.
Measured: 12 weeks
Secondary outcomes (1)
Wound Closure
Assessing how many patients wounds closed during the study and the time in weeks it took for the patient to close their wound.
Measured: Until the wound is closed up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start31 Mar 2021
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same intervention.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Keystone Pharmacy
- Responsible party
- Sponsor
- Investigators
- Laura R Vick, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076955
- Sponsor's protocol ID
- 2021-UMC014
- Status last verified
- Sep 2021
- First submitted
- 30 Sep 2021
- Last updated
- 13 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share deidentified data that is collected in the study in full. All IPD that will result in publication.
Publications
Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346.
PubMed 22619242Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.
PubMed 29377202
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Healing of Diabetic Foot Ulcers With Compounded Anti-Infective Irrigation
- ClinicalTrials.gov ID
- NCT05076955
- Acronym / sponsor ID
- 2021-UMC014
- Conditions
- Diabetic Foot Ulcer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Collaborators
- Keystone Pharmacy
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 13 Oct 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.
Diabetic foot ulcers (DFUs) are a frequent clinical problem observed in diabetic patients. Properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnostic and therapeutic approaches. The purpose of this study is to evaluate the effectiveness of a compounded, anti-infective irrigation therapy to increase the healing rates of diabetic foot ulcers and thereby provide a new therapeutic option for health care providers treating high-risk patients with DFUs regardless if secondary fungal infections are present.
Participants diagnosed with diabetes type 1 or 2 and with a documented open diabetic foot ulcer/wound with or without a secondary fungal infection will be included in this prospective, active intervention pilot study. Healing rates will be evaluated every two weeks following the initiation of study therapy up to three months. Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. Participants will be asked to return to clinic every two - four weeks for assessment of the ulcer and compliance with treatment.
A sample size of approximately 100 patients is estimated to have 90% power to detect 15% improvement in ulcer healing rates to 45% and 35% compared to historical benchmarks of approximately 30% for ulcers of <6 months duration and 20% for ulcers ≥6 months duration and/or prior treatment failure, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same intervention.
| Arm | Type | Receives |
|---|---|---|
| Treatment of Diabetic Foot Ulcer | Experimental | Drug: vancomycin-tobramycin-itraconazoleParticipants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. This is an irrigating foot bath with a compounded medication of vancomycin-tobramycin-itraconazole. This medication with combined 3/4 gallon of water. Participant will soak foot in solution for 10 minutes per day. Daily until wound is healed for a minimum of 4 weeks and a maximum of 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 1 or Type 2 diabetes mellitus
- An open DFU / wound of any size (including those requiring debridement in operation room or clinic setting) with or without a secondary fungal infection
- ≥ 18 years of age
- Treatment naïve or treatment failure with oral antibiotics to current wound infection
Key exclusion criteria (9 listed)
- Patients who present with untreated or on active-treatment for osteomyelitis, exposed bone, or have a life-threatening need of immediate surgery.
- Patients who are allergic to any components of the investigated product.
- Patients who have ≥ 15 shoe size
- Patients who have received IV antibiotics within the past 30 days
- Patients with HgbA1C > 14
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 |
|---|---|---|
| vancomycin-tobramycin-itraconazoleParticipants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. This is an irrigating foot bath with a compounded medication of vancomycin-tobramycin-itraconazole. This medication with combined 3/4 gallon of water. Participant will soak foot in solution for 10 minutes per day. Daily until wound is healed for a minimum of 4 weeks and a maximum of 3 months. | Drug | Treatment of Diabetic Foot Ulcer |
Primary outcome
Healing Rate
Time frame: 12 weeks
We will be looking at measurements of the wound at the start of the study and at each study visit until the wound is healed, or the study has ended. The wounds are measured with a ruler by the provider seeing the patient at the time of the visit in centimeters. The wounds are also photographed with a ruler in the photograph for size.
1 secondary outcome
Wound Closure
Time frame: Until the wound is closed up to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2021.
- Background: PubMed 22619242Lipsky BA, Berendt AR, Cornia PB, Pile JC, Peters EJ, Armstrong DG, Deery HG, Embil JM, Joseph WS, Karchmer AW, Pinzur MS, Senneville E; Infectious Diseases Society of America. 2012 Infectious Diseases Society of America clinical practice guideline for the diagnosis and treatment of diabetic foot infections. Clin Infect Dis. 2012 Jun;54(12):e132-73. doi: 10.1093/cid/cis346.
- Background: PubMed 29377202Everett E, Mathioudakis N. Update on management of diabetic foot ulcers. Ann N Y Acad Sci. 2018 Jan;1411(1):153-165. doi: 10.1111/nyas.13569.
- Individual participant dataSharing planned: Yes. We plan to share deidentified data that is collected in the study in full. All IPD that will result in publication.
Related trials for Diabetic Foot Ulcer
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Diabetes, Peripheral Neuropathy
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Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
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Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
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Better Care Closer to Home: Enhancing Primary and Community Care
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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.
Laura R Vick, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing vancomycin-tobramycin-itraconazole in people with Diabetic Foot Ulcer, run by University of Mississippi Medical Center at 1 site 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Oct 2021. 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Laura R Vick, MD (601-278-6213, lvick@umc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05076955, which also lists 2 linked publications.
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 13 Oct 2021.