Diabetic Foot Ulcer
Conditions
Keywords
Diabetic, Ulcer, Wound
Brief 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 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.
Interventions
DRUGdoxycycline
1.0% doxycycline gel applied topically to the wound once daily for 20 weeks
DRUGplacebo gel
placebo gel applied topically to the wound once daily for 20 weeks
Sponsors
NanoSHIFT LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Without Adverse Events | every 2 weeks | Participants were monitored for 20 weeks during the study. |
Secondary
| Measure | Time frame |
|---|---|
| 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) | baseline, week 4, week 10, week 20 |
Countries
United States
Participant flow
Recruitment details
subjects were recruited through the local veterans administration clinics
Pre-assignment details
adult subjects with diabetic lower extremity ulcers were enrolled into the study after determination that the wound was not infected
Participants by arm
| Arm | Count |
|---|---|
| NanoDOX™ Hydrogel 1.0% doxycycline gel | 8 |
| Placebo placebo gel | 7 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 3 |
Baseline characteristics
| Characteristic | Placebo | NanoDOX™ Hydrogel | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 4 Participants | 3 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Continuous | 68.86 years STANDARD_DEVIATION 9.75 | 64.99 years STANDARD_DEVIATION 11.53 | 66.33 years STANDARD_DEVIATION 10.53 |
| Region of Enrollment United States | 7 participants | 8 participants | 15 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
Primary
Number of Participants Without Adverse Events
Participants were monitored for 20 weeks during the study.
Time frame: every 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| NanoDOX™ Hydrogel | Number of Participants Without Adverse Events | 8 participants |
| Placebo | Number of Participants Without Adverse Events | 7 participants |
Secondary
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