Amnio-Maxx for Foot Ulcer
Recruiting in Palo Alto (17 mi)
+5 other locations
Overseen byWindy Cole, DPM
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Capsicure, LLC
Must be taking: Oral glycemic, Insulin
Must not be taking: Immunosuppressants, Chemotherapy, Topical steroids
Disqualifiers: Cancer, Cardiovascular, Renal, others
Stay on Your Current Meds
No Placebo Group
Trial Summary
What is the purpose of this trial?
This randomized controlled study evaluates the adjuvant use of Amnio-Maxx in patients with diabetic foot ulcers
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants, certain chemotherapy, or topical steroids, you may need to stop these before joining the trial.
What data supports the effectiveness of the treatment Amnio-Maxx for foot ulcers?
Is Amnio-Maxx safe for use in humans?
How does the Amnio-Maxx treatment for foot ulcers differ from other treatments?
Amnio-Maxx is unique because it uses a dehydrated amniotic membrane, which is a type of biological dressing derived from the human placenta, to help heal foot ulcers. This treatment is different from standard care as it aims to accelerate wound healing by providing a natural scaffold that supports tissue regeneration.13458
Eligibility Criteria
This trial is for adults over 18, with Type I or II Diabetes Mellitus and a diabetic foot ulcer present for more than 4 weeks but less than a year. The ulcer should be between 2.0 cm² and 25 cm² in size after cleaning, not healing well, and have adequate blood flow to the foot. People over 65 are especially encouraged to join.Inclusion Criteria
I am 18 or older, and I understand the study aims to enroll many people over 65.
I am willing and able to follow the study's requirements.
I have signed the informed consent form.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2 weeks
Run-in
Participants complete a 2-week run-in period prior to treatment allocation
2 weeks
Treatment
Participants receive Amnio-Maxx and standard of care or standard of care alone for 12 weeks
12 weeks
Weekly visits (± 3 days), additional visits as needed for dressing changes
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Amnio-Maxx (Other)
Trial OverviewThe study tests Amnio-Maxx as an additional treatment for diabetic foot ulcers that haven't improved with standard care alone. It's a randomized controlled trial, meaning participants will be randomly assigned to receive either Amnio-Maxx or continue only with their current treatment.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Amnio-Maxx as an addition to standard of careExperimental Treatment1 Intervention
Device exposure is estimated to be a maximum of 12 weeks
Group II: No intervention: Standard of CareActive Control1 Intervention
Debridement, offloading, and proper moisture balance dressings
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Quality Care Clinical ResearchMiami, FL
North Alabama Research Center, LLCAthens, AL
Evolution Research CenterHialeah, FL
Stride Clinical ResearchHouston, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Capsicure, LLCLead Sponsor
References
Evaluation of the effect of a gel made with amniotic fluid formulation on the healing of diabetic foot ulcers: A triple-blind clinical trial. [2023]The aim of this study was to evaluate the effect of a gel made with amniotic fluid (AF) formulation on wound healing in diabetic foot ulcers.
An evaluation of dehydrated human amniotic membrane allografts in patients with DFUs. [2022]To evaluate healing of chronic diabetic foot ulcers (DFUs) with use of dehydrated human amniotic membrane (dHAM) in patients failing under standard of care treatment.
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).
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.
The effectiveness of a new dried human amnion derived membrane in addition to standard care in treating diabetic foot ulcers: A patient and assessor blind, randomised controlled pilot study. [2021]Recent reviews suggest that amniotic membrane products may accelerate healing of diabetic foot ulcers. A new dried human amniotic membrane (dHAM) has been used for ocular ulcers but not for diabetic foot ulcers. This was a multi-centre, prospective, patient and observer blind, randomised controlled pilot trial, to investigate whether 2 weekly addition of the dHAM to standard care versus standard care alone increased the proportion of healed participants' index foot ulcers within 12 weeks. Thirty-one people (mean age 59.8 years, 81% male, 87% type 2 diabetes) were randomised (15 dHAM, 16 usual care). Within 12 weeks, healing occurred in 4 (27%) ulcers in the dHAM group versus 1 (6.3%) usual care group (P = .1). Percentage wound area reduction was higher in the dHAM versus control group. (P = .0057). There was no difference in AEs between the two groups. Six participants allocated to dHAM correctly identified their treatment group, although 5 in usual care incorrectly thought they were in the intervention arm. This pilot trial result is encouraging showing that this dHAM preparation is safe and promising treatment. These results will be used to design a statistically powered, definitive double blind randomised controlled trial.
Human amniotic membrane allograft, a novel treatment for chronic diabetic foot ulcers: A systematic review and meta-analysis of randomised controlled trials. [2021]To evaluate the efficacy and safety of human amniotic membrane (HAM) allograft in treating chronic diabetic foot ulcers (DFUs), a comprehensive search of randomised controlled trials in MEDLINE, EMBASE, PubMed, CENTRAL and Web of Science was conducted to December 7, 2019. Two reviewers independently screened the studies, extracted data, and evaluated the quality of studies. The primary outcome was the proportion of complete healing. The secondary outcomes were mean time to complete healing and adverse events. Statistical analyses were performed using RevMan 5.3. We identified 257 articles, of which 7 articles (465 participants) were included in the meta-analysis. The proportion of complete wound healing in HAM plus standard of care (SOC) group was 3.88 times as high as that in SOC alone (RR: 3.88 [95% CI: 2.34, 6.44]) at 6 weeks, and 2.01 times at 12 weeks (RR: 2.01 [95%CI: 1.45, 2.77]). The intervention group had a significantly shorter time to complete healing (MD: -30.33 days, [95% CI: -37.95, -22.72]). The number needed to treat within 6 weeks was 2.3 ([95% CI: 1.8, 3.1]). No significant difference was shown in adverse events. Results were consistent in a sensitivity analysis. Hence, HAM plus SOC is effective and safe in treating chronic DFUs.
A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers. [2020]Aim: Determine the effectiveness of hypothermically stored amniotic membrane (HSAM) versus standard of care (SOC) in diabetic foot ulcers (DFUs). Methods: A randomized controlled trial was conducted on 76 DFUs analyzed digitally. Results: Cox wound closure for HSAM (38 wounds) was significantly greater (p = 0.04) at weeks 12 (60 vs 38%), and 16 (63 vs 38%). The probability of wound closure increased by 75% (Hazard Ratio = 1.75; 95% CI: 1.16-2.70). HSAM showed >60% reductions in area (82 vs 58%; p = 0.02) and depth (65 vs 39%; p = 0.04) versus SOC. Conclusion: HSAM increased frequency and probability of wound closure in DFUs versus SOC.
Implications for the use of amnion and chorion in podiatric medicine and surgery. [2009]The purpose of this article is to show the possibility of using fetal membranes as a biologic dressing for some of the pedal ulcerations that podiatrists encounter. There are as many treatment modalities for lower extremity ulcerations as there are types of ulcers. Through the following case histories, the authors demonstrate various types of ulcerations treated with amnion and chorion and the results achieved. The clinical application of fetal membranes has been under study for many years. The authors' efforts support the use of amnion and chorion by the medical community in treating some lower extremity ulcers.