Diabetic Foot Ulcer Clinical Trial
Official title:
Effectiveness of MIRODERM® Biologic Wound Matrix in the Treatment of Hard-to-Heal Diabetic Foot Ulcers
This study will assess the ability of MIRODERM to heal difficult diabetic foot ulcers within 12 weeks of treatment.
The primary objective of this study is to determine the number of successful complete wound
closures within 12 weeks of treatment with MIRODERM Fenestrated Biological Wound Matrix. Some
secondary objectives of this study include documenting the time course of wound healing and
assessing changes in quality of life.
The primary cohort is individuals suffering from a diabetic foot ulcer that has not been
healed in the last 3 months and after at least 2 attempts with an advanced biologic. Ulcer
will be between 1 and 12 cm squared, less than 5 mm deep, full thickness, below the ankle,
and with no exposed bone or tendon. Subjects will be 18 or older, have Type I or II diabetes
with adequate vascular profusion. Subjects will be unable to participate if they have
osteomyelitis, Charcot foot, a known collagen vascular disease, are on dialyses, are
immunocompromised or have an HbA1c level equal to or great than 12%.
This is a single-arm study with no Independent Variables. Descriptive data to be collected
will include demographics, pathology and medical history.
Outcome assessments:
- proportion of subjects with 100% epithelialization of wound
- SF-36
- Adverse events
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04497805 -
Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers
|
Phase 2 | |
| Withdrawn |
NCT03675269 -
Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer:
|
N/A | |
| Completed |
NCT04624516 -
Effect of Self-foot Exercise on the Incidence of Plantar Foot Diabetic Ulcer Recurrence
|
N/A | |
| Not yet recruiting |
NCT06439667 -
VIRTUALLY SUPERVISED TELE-EXERCISE PLATFORM FOR ACCELERATING PLANTAR WOUND HEALING
|
||
| Recruiting |
NCT05608187 -
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
|
Phase 2 | |
| Not yet recruiting |
NCT06437028 -
Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of Diabetic Foot Ulcers.
|
N/A | |
| Not yet recruiting |
NCT06278935 -
Lifestyle Tailored Offloading for Diabetic Foot Ulcers
|
N/A | |
| Withdrawn |
NCT05024656 -
AmnioExcel® Plus vs SOC in the Management of Diabetic Foot Ulcers
|
N/A | |
| Terminated |
NCT02202668 -
Transcutaneous Raman Spectroscope (TRS) Analyses of Diabetic Foot Ulcers
|
N/A | |
| Terminated |
NCT01966380 -
Proof of Concept (Design Validation) in Patient With Hard to Heal Wounds Such as Pressure Ulcer, Diabetic Foot Ulcer and Leg Ulcer, Leia
|
Phase 2 | |
| Completed |
NCT01951768 -
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection
|
Phase 4 | |
| Completed |
NCT01657474 -
Comparative Study of Two Application Regimens of Amniotic Membrane Wound Graft In the Management of Diabetic Foot Ulcers
|
N/A | |
| Active, not recruiting |
NCT00389636 -
TheraGauze™ Alone and Regranex®Gel 0.01% Plus TheraGauze™ in the Treatment of Wagner Stage I Diabetic Foot Ulcers
|
N/A | |
| Completed |
NCT01181440 -
Dermagraft(R) for the Treatment of Patients With Diabetic Foot Ulcers
|
Phase 3 | |
| Enrolling by invitation |
NCT05888259 -
Plantar Pressure Distribution in Diabetic Foot Ulcer
|
N/A | |
| Completed |
NCT04054804 -
Digital Foot Check by Using the D-Foot, a New Software
|
||
| Not yet recruiting |
NCT05877378 -
Efficacy of PICO Single-use System in Chronic Ulcers
|
N/A | |
| Recruiting |
NCT06037369 -
The Short Message-based Customized Standardized
|
N/A | |
| Completed |
NCT03312595 -
Clinical Outcomes After Treatment With RestrataTM Wound Matrix in Diabetic Foot Ulcers (DFU)
|
N/A | |
| Recruiting |
NCT04564443 -
A Unique Micro Water Jet Technology Device Versus Standard Debridement in the Treatment of Diabetic Foot
|
N/A |