NCT06172218已完成不适用
Prospective, Randomized Controlled Pilot Study Assessing Micronized Amniotic Membrane and Umbilical Cord Particulate in Patients With Symptomatic and Refractory Achilles Tendinopathy
North Park Podiatry2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年11月22日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Achilles pain
研究概览
简要总结
To evaluate outcomes after use of micronized amniotic membrane to replace or supplement damaged or inadequate integumental tissue in patients with "chronic" insertional or non-insertional Achilles tendinopathy that remains refractory to standard care. Outcomes between a control and treatment group in this pilot study will be used to devise a multi-center study with larger sample size.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 64 years old
- •BMI ≤ 40 kg/m2
- •Subject has been diagnosed with unilateral Achilles tendinopathy (based on investigator assessment using ultrasound) of at least 3 months duration
- •History of having attempted a physical therapy for Achilles tendinopathy which must have included at least 6 weeks of eccentric exercise, alone or in addition to other non-surgical therapies
- •VISA-A score for the target tendon ≥40 and ≤60 at screening
- •Subject is willing to comply with all study procedures
- •Willing to sign a written informed consent to participate
- •Able to follow study instructions, with the intention of completing all required visits
排除标准
- •Planned surgical procedure below knee of the targeted extremity during study period
- •Patient has previously received an injection for this injury within the past 2 months
- •Major lower limb amputation of the contralateral leg
- •A medical condition, or a personal situation, which in the principal investigator's opinion, is not appropriate for participation in the trial
- •Osteoarthritis, chronic low back pain, fibromyalgia or any other condition that may affect the responses on the VISA-A
- •HIV infection, Hepatitis B or C infection, tuberculosis, COVID-19, cellulitis or any other active infection
- •Cognitive impairment, mental illness, neuroses, or untreated depression that would preclude understanding or reliably completing the patient reported outcome measures
- •Peritendinopathy, paratenonitis, partial tear or tendon rupture of the affected tendon
- •Subject has hindfoot deformities on the targeted extremity
- •Plantar fasciitis, calcaneal bursitis, Sever's disease, retrocalcaneal exostosis (Mulholland deformity, Haglund's deformity), enthesophytes, myofascial pain referral, posterior ankle impingement, os trigonum syndrome, tenosynovitis or dislocation of the peroneal or other plantar flexor tendons, an accessory soleus muscle, irritation or neuroma of the sural nerve, or systemic inflammatory disease
- •Leg length discrepancy, hyperpronation, varus deformity of the forefoot, pes cavus or limited mobility of the subtalar joint
- •Prior surgical intervention to the affected tendon
- •Current use of vitamins or herbal supplements
- •Current use of opioids, midazolam, gabapentin, pregabalin or ketamine
- •Compensable disability or work injury, ongoing litigation, or ongoing chiropractic care
- •Current use of systemic immunosuppressive medications, chemotherapy, or history of organ transplant (kidney, heart, lung)
- •Pregnancy and women who are expecting to be pregnant
- •Current enrollment in another interventional drug or device study or participation in such a study within 30 days of anticipated entry into this study
研究组 & 干预措施
Micronized Amniotic Membrane
Experimental
Injection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl
干预措施: Flo (Other)
Micronized Amniotic Membrane
Experimental
Injection of micronized amniotic membrane reconstituted in 2.0 mL sterile, preservative free 0.9% NaCl
干预措施: Saline (Other)
Preservative Free Normal Saline
Placebo Comparator
2.0 mL sterile, preservative free 0.9% NaCl
干预措施: Saline (Other)
结局指标
主要结局
Change in Achilles pain
时间窗: 30 days
A score of 0 is considered no pain while a score of 10 is considered very severe pain
次要结局
- Change from Baseline in NRS score(over 3 months)
- Time to complete pain relief(over 3 months)
- Proportion of responders based on change in VISA-A score(over 3 months)
- Proportion of complete pain relief(over 3 months)
- Change from Baseline in VISA-A score(over 3 months)
- Proportion of subjects that respond feeling at least better and satisfied(3 months)
研究者
Trent Brookshier
Podiatrist/ Founder
North Park Podiatry
研究点 (2)
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