Amniotic Tissue Treatments for Diabetic Foot Ulcers
Recruiting in Palo Alto (17 mi)
+8 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tides Medical
No Placebo Group
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?The purpose of this clinical investigation is to evaluate the safety and efficacy of Amnion/Chorion/Amnion allograft , Amnion/Chorion allograft, and/or Amnion/Amnion allograft, plus Standard of Care (SOC) each versus SOC alone in the treatment of chronic non-healing diabetic foot ulcers (DFU) after 12 weeks of treatment.
How is the amniotic tissue treatment different from other treatments for diabetic foot ulcers?
Amniotic tissue treatment for diabetic foot ulcers is unique because it uses a natural membrane from the placenta, which can enhance healing by reducing pain, drainage, and infection, and speeding up recovery time compared to traditional methods.
15789What data supports the effectiveness of the treatment Amniotic Tissue(s) for diabetic foot ulcers?
Research shows that amniotic tissue treatments, like amnion/chorion allografts, help heal chronic diabetic foot ulcers by improving wound closure, reducing healing time, and decreasing pain and infection. Studies comparing these treatments to standard care have demonstrated their effectiveness in accelerating the healing process for these types of wounds.
34789Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have been on immune-suppressants, certain chemotherapy drugs, or topical steroids on the ulcer within a month before the study. If you are on any investigational drugs or products, you must stop them at least 30 days before the study.
Is amniotic tissue treatment safe for humans?
Research shows that amniotic tissue treatments, like dehydrated human amnion/chorion membrane allografts, are generally safe for humans. In a study with five patients, there were no adverse events reported, indicating that the treatment is safe to use.
24569Eligibility Criteria
This trial is for individuals with chronic non-healing diabetic foot ulcers. Participants should have a history of diabetes and an open wound on the foot that hasn't healed over time despite standard care.Inclusion Criteria
My ulcer is between 1.0 and 25 cm2 in size.
I am 18 years old or older.
I have a deep foot ulcer below my inner ankle.
Exclusion Criteria
My wound is infected.
I have had radiation treatment at the site of my ulcer.
My ulcer has not been treated with any therapies that are not allowed.
I have been diagnosed with HIV or Hepatitis C.
My diabetes is not well-controlled, with an HbA1c over 12.0 recently.
My kidney function is severely impaired with a creatinine level of 3.0 mg/dL or higher.
My ulcer has shrunk by 30% or more after 2 weeks of standard treatment.
I have Charcot foot in one of my limbs.
Participant Groups
The study is testing the safety and effectiveness of different types of amniotic tissue treatments (Amnion/Chorion/Amnion, Amnion/Chorion, or Amnion/Amnion allografts) plus standard care versus just standard care alone in healing diabetic foot ulcers after 12 weeks.
4Treatment groups
Experimental Treatment
Active Control
Group I: "Amnion/Chorion/Amnion" common/general allograft configurationExperimental Treatment1 Intervention
Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a tri-layer dehydrated amniotic membrane allograft for the treatment of DFUs. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage.
Group II: "Amnion/Chorion" common/general allograft configurationExperimental Treatment1 Intervention
Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dehydrated human amniotic membrane allograft comprised of a tri-layer membrane (amnion/intermediate layer/chorion) which provides a natural scaffold that allows cellular attachment and infiltration. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed.
Group III: "Amnion/Amnion" common/general allograft configurationExperimental Treatment1 Intervention
Topical application of placental allograft on to surface of open chronic diabetic foot ulcer using a dual layer dehydrated human amniotic membrane allograft. Human amniotic membrane is a thin collagenous membrane derived from the submucosa of the placenta, the organ that connects the developing fetus to the mother's uterus. A human amniotic membrane consists of multiple layers including epithelial cells, a basement membrane, and a stromal matrix which provides a natural scaffold that allows cellular attachment or infiltration and growth factor storage. This allograft provides a protective cover and supports the body's wound healing process. This allograft is supplied sterile and not intended to be removed.
Group IV: Standard of CareActive Control1 Intervention
Standard of Care (SOC) for open chronic diabetic foot ulcer using a calcium alginate dressing and will have a silicone non-adherent dressing (MepitelTM or equivalent), a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll, compressive wrap and Coban (Threeflex 3-layer or equivalent) applied. Offloading of the DFU (removable offloading boot or total contact casting \[TCC\] if the subject's foot is too large for a removable offloading boot), appropriate sharp or surgical debridement, and infection management. Graft provides a protective cover and supports the body's wound healing processes. This allograft is supplied sterile and not intended to be removed.
Amniotic Tissue(s) is already approved in United States for the following indications:
🇺🇸 Approved in United States as Dehydrated Amniotic Membrane Allograft for:
- Chronic non-healing diabetic foot ulcers
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Clever Medical ResearchMiami, FL
Foot and Ankle Specialists of the Mid-AtlanticSalem, VA
Lower Extremity Institute of Research and TherapyBoardman, OH
Limb Preservation Platform IncFresno, CA
More Trial Locations
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Who is running the clinical trial?
Tides MedicalLead Sponsor
Professional Education and Research InstituteCollaborator
References
Using amniotic membrane allografts in the treatment of neuropathic foot ulcers. [2016]Neuropathic foot ulcers are a common complication in patients with diabetes. These ulcers are often slow to heal and can lead to infection, further tissue destruction, osteomyelitis, and amputation. These patients pose a challenge to clinicians who must determine the best treatment options while balancing the risks, benefits, and costs. Conservative therapies often present disappointing results, and a number of newer "biologic bandages" have been developed to better assist the healing process. We describe results from diabetic patients with neuropathic foot ulcers treated with a new amniotic membrane-based allograft.
Amniotic membrane is a potential regenerative option for chronic non-healing wounds: a report of five cases receiving dehydrated human amnion/chorion membrane allograft. [2021]A case series of five patients with a total of six chronic non-healing wounds (>30 day duration) were non-randomly selected to evaluate the performance, safety and handling properties of dehydrated human amnion/chorion membrane allograft, an amniotic membrane scaffolding product. The patients had lower extremity wounds that had previously failed standard of care within a university outpatient/inpatient wound healing programme. Five wounds treated with dehydrated amnion/chorion membrane allograft showed a mean 43% area reduction from baseline (51% median) at 3 weeks into treatment and completely healed with a 64-day median time to closure (SD ±27·6 days). One wound worsened at 3 weeks and was found to have a complete central vein obstruction that was treated with long-term mild compression but still eventually healed at 6 months. Removing this outlier, the four responding wounds had a 72% mean and 69% median change in area from baseline, at the 3 week point. All five patients received only one application of dehydrated human amnion/chorion membrane allograft, and there were no adverse events. The product was easy to use, administer and handle. In summary, dehydrated human amnion/chorion membrane allograft appears to be a safe, effective and easy to use therapy for chronic non-healing wounds. This study describes the details of these clinical cases and provides an overview of the current evidence on the use of amniotic tissue in clinical practice.
A Prospective, Randomized, Multicenter, Controlled Evaluation of the Use of Dehydrated Amniotic Membrane Allograft Compared to Standard of Care for the Closure of Chronic Diabetic Foot Ulcer. [2017]Delayed closure of foot ulcers is a primary factor leading to lower extremity amputation in patients with diabetes, creating great demand for products or therapies to accelerate the rate of wound closure in this population. This study (ClinicalTrials.gov Identifier: NCT02209051) was designed to evaluate dehydrated amniotic membrane allograft (DAMA) (AMNIOEXCEL, Derma Sciences Inc, Princeton, NJ) plus standard of care (SOC) compared to SOC alone for the closure of chronic diabetic foot ulcers (DFUs).
Aseptically Processed Placental Membrane Improves Healing of Diabetic Foot Ulcerations: Prospective, Randomized Clinical Trial. [2022]Allogeneic grafts derived from amnion/chorion are known to be efficacious in healing chronic diabetic foot ulcerations (DFUs). The goal of this study was to compare aseptically processed dehydrated human amnion and chorion allograft (dHACA) versus standard of care (SOC) in facilitating wound closure in nonhealing DFUs.
Efficacy and Time Sensitivity of Amniotic Membrane treatment in Patients with Diabetic Foot Ulcers: A Systematic Review and Meta-analysis. [2020]Diabetic foot ulcers (DFUs) are complex chronic wounds which have a major long-term impact on the morbidity, mortality and quality of patients. The objective of this study was to assess the efficacy and time sensitivity of human amnion/chorion membrane treatment in patients with chronic DFUs.
Enhanced Skin Regeneration Using a Novel Amniotic-derived Tissue Graft. [2018]Chronic and recalcitrant wounds present a significant therapeutic challenge. Amniotic tissues contain many regenerative cytokines, growth factors, and extracellular matrix molecules including proteoglycans, hyaluronic acid, and collagens I, III, and IV. Dehydrated amnion/chorion grafts are currently used to treat a variety of wounds such as diabetic foot ulcers and burns.
Amnion: The Ideal Scaffold for Treating Full-Thickness Wounds of the Lower Extremity. [2022]Amnion and amniotic tissue has been studied for more than 100 years in the treatment of acute and chronic wounds. Recent studies have focused on the use of amnion tissue in the management of full-thickness diabetic wounds, particularly of the lower extremities. With new harvesting, processing, and distribution technologies, amnion is increasingly available in treating these wounds. Current data and research show increased healing potential and decreased healing times, pain, drainage, and infection in wounds treated with amnion products. There are a variety of amnion products with varying differences and purposes, requiring additional research and comparison trials.
Human placental membrane as a wound cover for chronic diabetic foot ulcers: a prospective, postmarket, CLOSURE study. [2019]To evaluate the safety and efficacy of a chorioamniotic allograft, used as a wound cover for chronic foot ulcers, in patients with diabetes.
Human Amnion Chorion Membrane Allografts in the Treatment of Chronic Diabetic Foot Ulcers: A Literature Review. [2023]To discuss human amnion chorion (placental) membrane allograft (HACMA) use for the treatment of chronic diabetic foot ulcers (DFUs) and to evaluate the effectiveness, cost, and product waste of this therapy.