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Tests treatment safety and results for Diabete Mellitus
Official title Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
ClinicalTrials.gov ID: NCT07326553
What this study is testing
What is Placental Membrane?
Placental Membrane is an investigational medicine, being studied as a potential treatment for diabete mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Evaluation of Efficacy of Placental Membrane Dressings in Accelerating Diabetic Foot Healing
- 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 45 to 85
You may be able to join if
- Patient has signed the informed consent form.
- Male or female patient at least 18 years of age or older, as of the date of the screening visit.
- Confirmed diagnosis of Type 1 or Type 2 DM.
- Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at...
- The DFU has been present for ≥4 weeks and ≤12 months.
You likely can't join if
- Hemoglobin A1c (HbA1c) level is \> 10%.
- Chronic oral steroid use of \> 7.5 mg daily within the previous 30 days preceding screening.
- Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
- Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
- Pregnant or lactating women.
See the full eligibility criteria
- Patient has signed the informed consent form.
- Male or female patient at least 18 years of age or older, as of the date of the screening visit.
- Confirmed diagnosis of Type 1 or Type 2 DM.
- Has a DFU that is located below the malleoli ranging in size from 1.0 cm2 to 20.0 cm2, post debridement, when measured by the investigator staff at the screening visit using the eKare device.
- The DFU has been present for ≥4 weeks and ≤12 months.
- The DFU is non-healing as defined as \<30% reduction in size in response to standard of care from Screening (Visit 1) to Study Day 1 (Visit 2).
- If more than one ulcer is present the selected target ulcer must be at least 2 cm from the nearest edge of any adjacent ulcers.
- The depth of the target foot ulcer is graded as Wagner Grade I or II, i.e., with no evidence of exposed muscle, tendon, bone, or joint capsule.
- Arterial supply adequacy to the foot with the target ulcer confirmed by any one of the following and documented in medical record/EMR:
- Great toe pressure ≥ 40 mm/Hg
- Systolic blood pressure Ankle Brachial Index (ABI) in the range ≥ 0.70 ≤ 1.20
- TcPO2 ≥ 30 mmHg from the foot
- Toe Brachial Index or TBI ≥ 0.65
- Willing to follow all instructions given by the Investigator, return for all visits, and adhere to off-loading protocols while on the study.
- Hemoglobin A1c (HbA1c) level is \> 10%.
- Chronic oral steroid use of \> 7.5 mg daily within the previous 30 days preceding screening.
- Chronic oral or parenteral corticosteroids, or any cytotoxic agents within the previous 30 days preceding screening.
- Has tested positive for Human Immunodeficiency Virus (HIV) or has Acquired Immune Deficiency Syndrome (AIDS).
- Has malignancy or history of cancer in 5 years preceding the screening visit other than non- melanoma skin cancer.
- Pregnant or lactating women.
- Women of child-bearing potential who are unwilling to avoid pregnancy or use an effective form of birth control.
- Currently on dialysis or planning to start dialysis.
- Is currently enrolled or participated in another device, drug, or biological trial within 30 days of screening.
- Has used wound treatments with enzymes, growth factors, living skin, dermal substitutes including other amniotic or umbilical cord tissue therapies, or other advanced biological therapies within the last 30 days.
- Current use of topical anti-microbial or silver-containing products.
- Target ulcer is over an active or inactive Charcot deformity.
- The depth of the target ulcer is graded as Wagner Grade III or higher, i.e., with evidence of exposed muscle, tendon, bone, and/or joint capsule.
- Gangrene is present on any part of the affected foot.
- Current suspicion of osteomyelitis, cellulitis, or other clinical signs or symptoms of target ulcer infection.
- Any previous use of human placental membrane applied to the target ulcer.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
- Houston, Texas, 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, 45 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States; Houston, Texas, United States. 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.