Diabetic Foot Ulcer Clinical Trial
Official title:
The Physiological Effects of Remote Ischemic Conditioning on the Healing of Diabetic Foot Ulcers
Study type: Randomized, double blinded, interventional, single-site study. Two groups: Active
receiving RIC therapy from the LifeCuff device and standard of care treatment without RIC.
Study population: Adults (18 to 90) with diabetes myelitis presenting with diabetic foot
ulcers.
Randomization and sample size: Subjects will be allocated on a 1:1 ratio, yielding a minimum
per protocol population (PP Population) of 15 patients in the Active group and 15 in the
control group.
Study timeline: Total amount of time from the Screening Visit to the Final Visit is
approximately 16 weeks. For patients who meet inclusion criteria, they are randomized into
Active or Control treatment groups. In addition they are stratified into groups based on
wound etiology: neuropathic (defined as insensate at 2 or more of 5 sites verified by
insensitivity to the 5.07 Semmes-Weinstein 10 g monofilament), ischemic (defined as ABI of
0.7 neuro-ischemic (meeting both of above criteria) Subjects will present at DMU Foot and
Ankle Clinic on weeks 0, 3, 6, 9, and 12 for the following measurements: 40mL venous blood
draw (VEGF, SDF1a) 2mm punch biopsy (CD34+) Local wound perfusion (Laser Speckle[FK2] ) Ulcer
size measured by digital planimetry (TissueAnalytics)
n/a
| 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| Withdrawn |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| Withdrawn |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 |