Diabetic Foot UlcerPhase 2NCT00764361
Safety Study of Topical Doxycycline Gel for Adult Diabetic Lower Extremity Ulcers
A Phase 2 study testing doxycycline in people with Diabetic Foot Ulcer, run by NanoSHIFT LLC at 1 site in United States.
Trial summary
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating… 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?
- doxycycline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association
- Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:
- Agree to use a double-barrier method of contraception during their participation in this study;
- condoms (with spermicide) and hormonal contraceptives OR
- condoms (with spermicide) and intrauterine device OR
- intrauterine device and hormonal contraceptives OR
Show all 14Show fewer
- Abstains from sexual intercourse during their participation in this study OR
- Is with a same-sex partner and does not participate in bisexual activities where there is a risk of becoming pregnant
- Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening
- Be able to apply study drug to their ulcer, or have a caregiver do it
- Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg
- Target ulcer is Grade I according to the Wagner Grading Scale
- Quantitative bacterial count of of < 1.0 x 1.0E5 per gram of tissue for non-infected ulcers
- Quantitative bacterial count of ≥ 1.0 x 1.0E5 per gram of tissue for infected ulcers
Who cannot join
- Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
- Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
- Have more than three chronic ulcers present at baseline
- Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
- Have connective tissue disease
- Currently be going through kidney dialysis for renal failure
Show all 11Show fewer
- Have undergone treatment with doxycycline, Procuren®, or Regranex® within the last 30 days
- Have participated in another clinical research trial within the last 30 days
- Have a known history of osteomyelitis affecting to the area where the target ulcer is present
- Have any other concomitant condition which, in the opinion of the investigator, would make the subject unsuitable for the study.
- Subject has ulcers resulting from any cause other than diabetes (electrical burn, arterial insufficiency, chemical or radiation insult)
Trial locations and contacts
1 site in 1 country.
United States1 site
North Florida / South Georgia Veterans Administration Hospital
Gainesville, Florida, 32608
About this study
Official title: A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of NanoDOX™ Hydrogel(1.0% Doxycycline Monohydrate)in Diabetic Adult Subjects With Lower Extremity Ulcers Compared to Placebo Hydrogel.
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. During the run-in period patients with infected wounds will receive oral antibiotic and not be included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SOC treatment for diabetic ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.
Read the detailed description
Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.
- Conditions
- Diabetic Foot Ulcer
- Being tested
- doxycycline, placebo gel
- Keywords
- Diabetic, Ulcer, Wound
- Medical subject headings
- Diabetic Foot, Ulcer, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
doxycyclineDrug
1.0% doxycycline gel applied topically to the wound once daily for 20 weeks
placebo gelDrug
Also called doxycycline
placebo gel applied topically to the wound once daily for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| NanoDOX™ Hydrogel | Experimental | 1.0% doxycycline gel Receives: Drug: doxycycline |
| Placebo | Placebo comparator | placebo gel Receives: Drug: placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Without Adverse Events
Participants were monitored for 20 weeks during the study.
Measured: every 2 weeks
Secondary outcomes (1)
Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)
Measured: baseline, week 4, week 10, week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2008 (estimated)
- Study startJan 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NanoSHIFT LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Abernethy, MD, Study director, Alachua Government Services, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00764361
- Sponsor's protocol ID
- 2008-DOX-NT/003
- Status last verified
- Mar 2017
- First submitted
- 1 Oct 2008
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of NanoDOX™ Hydrogel(1.0% Doxycycline Monohydrate)in Diabetic Adult Subjects With Lower Extremity Ulcers Compared to Placebo Hydrogel.
- ClinicalTrials.gov ID
- NCT00764361
- Acronym / sponsor ID
- 2008-DOX-NT/003
- Conditions
- Diabetic Foot Ulcer
- Keywords
- Diabetic, Ulcer, Wound
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NanoSHIFT LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 2 Oct 2008 (estimated)
- Results
- Posted 5 Apr 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a double-blind, one center, two-arm study with a two (2) week Run-In, evaluating the efficacy of a once-daily administration of NanoDOX™ Hydrogel topically applied to diabetic ulcers in concert with professionally administered Standard of Care (SOC) procedures as described by Standard Operating Procedure(s) of the Department of Veterans Administration Hospitals. During the run-in period patients with infected wounds will receive oral antibiotic and not be included in the topical portion of the study until the infection is shown by wound fluid analysis to be resolved. Following a two (2) week Run-In of all patients to receive SOC treatment for diabetic ulcers, patients would have either the investigational material or the placebo hydrogel applied as a part of their wound care. Each patient would receive 1.5 gm packets of either the test article or the placebo hydrogel for a once-daily home treatment accompanied by a dressing change.
Detailed description
Study of NanoDOX vs placebo on diabetic ulcers of the lower leg/foot.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NanoDOX™ Hydrogel | Experimental | Drug: doxycycline1.0% doxycycline gel |
| Placebo | Placebo comparator | Drug: placebo gelplacebo gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Have a documented history of type I or type II diabetes mellitus as defined by the American Diabetes Association
- Women of childbearing potential must have a negative urine pregnancy test at screening and at baseline, and:
- Have an ulcer on the lower extremity (distal to a line connecting the medial and lateral malleoli) that has been present for at least 3 weeks and that is 1.2 cm2 to 4.0 cm2 at initial screening
- Be able to apply study drug to their ulcer, or have a caregiver do it
- Adequate blood flow to target ulcer extremity as measured by transcutaneous oxygen tension (TcpO2) of >30mmHg
Key exclusion criteria (11 listed)
- Be a pregnant or lactating woman or a female of childbearing potential who is not practicing acceptable form of birth control.
- Allergy to tetracycline, minocycline, demeclocycline, or any other known tetracycline derivative
- Have more than three chronic ulcers present at baseline
- Have undergone treatment with system corticosteroid or immunosuppressive therapy in the past 2 months
- Have connective tissue disease
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 |
|---|---|---|
| doxycycline1.0% doxycycline gel applied topically to the wound once daily for 20 weeks | Drug | NanoDOX™ Hydrogel |
| placebo gelAlso: doxycyclineplacebo gel applied topically to the wound once daily for 20 weeks | Drug | Placebo |
Primary outcome
Number of Participants Without Adverse Events
Time frame: every 2 weeks
Participants were monitored for 20 weeks during the study.
1 secondary outcome
Analyze the Molecular Changes in Pro-inflammatory Cytokine Levels That Occur in Diabetic Foot Ulcers as a Function of Healing Rate in the Presence /Absence of NanoDOX Hydrogel (1% Doxycycline Monohydrate Gel)
Time frame: baseline, week 4, week 10, week 20
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diabetic Foot Ulcer
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Active, not recruiting
Wearable Insoles for Recurrent Diabetic Ulcer Prevention
Diabetes, Peripheral Neuropathy
Active, not recruiting
Evaluation of Personalized Nutritional Intervention on Wound Healing of Cutaneous Ulcers in Diabetics
Foot, Diabetic
Not yet recruiting
Efficacy Evaluation of Turmeric-Derived Nanoparticle Hydrogel for the Treatment of Diabetic Foot Ulcer Wounds
Diabete Mellitus
Not yet recruiting
Better Care Closer to Home: Enhancing Primary and Community Care
Diabetic Foot Disease, Recurrence
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.
John Abernethy, MD study director
Alachua Government Services, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing doxycycline in people with Diabetic Foot Ulcer, run by NanoSHIFT LLC 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 14 inclusion and 11 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 7 Apr 2017. 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. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 5 Apr 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Without Adverse Events (time frame: every 2 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 7 Apr 2017.