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New treatment option for Diabetic Foot Ulcer
Official title Nonhealing Diabetic Foot Ulcers Treated With Standard of Care (SOC) Alone or Standard of Care and Amnion-Intermediate-Chorion (AIC)
ClinicalTrials.gov ID: NCT07014176
What this study is testing
- What it's testing
- The purpose of this study is to determine how well our dHPT (Dehydrated Human Placental Tissue) Product and Standard of Care work when compared to Standard of Care alone in achieving complete closure of diabetic foot.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people will be eligible to participate in the study if the following conditions exist:
- 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol).
- Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
You likely can't join if
- will be designated as the target ulcer.
- Subject must consent to using the prescribed off-loading method for the duration of the study.
- Subject must agree to attend study visits required by the protocol.
- Subject must be willing and able to participate in the informed consent process. Exclusion Criteria: people will be excluded from participation in...
- Known life expectancy of \< 6 months.
- Target ulcer is not secondary to diabetes.
See the full eligibility criteria
- people will be eligible to participate in the study if the following conditions exist:
- 18 years of age or older.
- Diagnosis of type 1 or 2 Diabetes mellitus.
- Hemoglobin A1c (HbA1c) level is \< 12% (108 mmol/mol).
- Target ulcer with a surface area at randomization of 0.7 cm2 to 20.0 cm2 measured post debridement.
- Target ulcer present for minimum of 4 weeks prior to screening visit.
- Target ulcer must be located on the foot with at least 50% of the ulcer below the malleolus.
- Target ulcer must be Wagner 1 or 2 grade, extending at least through the dermis or subcutaneous tissue and may involve the muscle provided it is below the medial aspect of the malleolus. The ulcer may not include...
- Affected limb must have adequate perfusion confirmed by vascular assessment. Any of the following methods performed within 3 months of the screening visit are acceptable:
- ABI ≥ 0.7 and ≤ 1.3;
- TBI ≥ 0.6;
- TCOM ≥ 40 mmHg;
- PVR: biphasic or triphasic.
- Subject with two or more ulcers must be separated by at least 2 cm. The largest ulcer satisfying the inclusion and
- will be designated as the target ulcer.
- Subject must consent to using the prescribed off-loading method for the duration of the study.
- Subject must agree to attend study visits required by the protocol.
- Subject must be willing and able to participate in the informed consent process. Exclusion Criteria: people will be excluded from participation in the study if any of the following conditions exist:
- Known life expectancy of \< 6 months.
- Target ulcer is not secondary to diabetes.
- Target ulcer is infected or there is cellulitis in the surrounding skin.
- Evidence of osteomyelitis complicating the target ulcer.
- Infection in the target ulcer or a location that requires systemic antibiotic therapy.
- Receiving immunosuppressants (including systemic corticosteroids at doses greater than 10 mg of Prednisone per day or equivalent) or cytotoxic chemotherapy is excluded.
- Topical application of steroids to the ulcer surface within one month of screening.
- Previous partial amputation on the affected foot if the resulting deformity impedes proper offloading of the target ulcer.
- Surface area of the target ulcer has reduced in size by more than 20% in the 2 weeks prior to screening visit ("historical" run-in period). Photographic planimetry is not required for measurements taken during the...
- Mini Nutritional Assessment (MNA) score of less than 17.
- Acute Charcot foot or an inactive Charcot foot that impedes proper offloading of the target ulcer.
- Women of childbearing potential (WOCBP) who are pregnant, considering becoming pregnant within the next 4 months, or are unwilling to use an appropriate form of contraception.
- Currently require dialysis or planning to start dialysis.
- Medical or psychological condition that, in the opinion of the investigator, may interfere with study assessments.
- Treated with hyperbaric oxygen therapy or a dehydrated human placental tissue (dHTP) in the 30 days prior to screening visit.
- Known sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.
- Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Rosa, California, United States
- Jacksonville, Florida, United States
- Chicago, Illinois, United States
- Mooresville, North Carolina, United States
- Rocky Mount, North Carolina, United States
- Allentown, Pennsylvania, United States
- Philadelphia, Pennsylvania, United States
- Hilton Head Island, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Santa Rosa, California, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Mooresville, North Carolina, United States; Rocky Mount, North Carolina, United States; Allentown, Pennsylvania, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.