Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04567563
Other study ID # IRB-2020-3
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 2020
Est. completion date November 2022

Study information

Verified date September 2020
Source Des Moines University
Contact Katherine Frush, DPM
Phone 515-271-1731
Email katherine.frush@dmu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Patient any gender between the ages of 18 and under 90 at the time of consent.

- Target ulcer has a minimum area of 1.0 cm2 and a maximum area of 20.0 cm2, measured at screening after sharp debridement, as assessed by computerized planimetry.

- Target ulcer open for a minimum of 4 weeks and a maximum of 52 weeks duration prior to the screening visit.

- Target ulcer is located on the toe or lateral dorsal, or plantar aspect of the foot with no portion on the ankle.

- Target ulcer is Grade IC (ischemic, non-infected superficial wound) or IIC (ischemic non-infected wound penetrating to tendon or capsule), according to the University of Texas Diabetic Wound Classification system.

- Adequate perfusion without critical limb ischemia, confirmed by vascular assessment of the affected foot through any of the following methods: ABI >0.7

- Confirmed diagnosis of type 1 or 2 diabetes mellitus

- Patient has a glycated hemoglobin A1c (HbA1c) level of less than 12%

- If patient has two or more ulcers, they must be separated by at least 2 cm and the largest one will be included as the study DFU though all will be similarly treated

- Patient is willing to use prescribed off-loading method during the whole duration of the study

- Patient available for the entire study period all follow up visit requirements, and able and willing to adhere to protocol requirements

- Patient able and willing to give written informed consent

Exclusion Criteria:

- Target ulcer is less than 1.0 cm2 measured at consent after sharp debridement

- Target ulcer is due to a non-diabetic etiology

- Presence in target ulcer of cellulitis, osteomyelitis or other clinical evidence of infection at time of enrollment.

- Presence of any foot ulcer (whether or not on the target foot) for which systemic antibiotic treatment is required.

- A history of more than 8 weeks' treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy, or application of topical steroids to the ulcer surface within one month prior to initial screening, or treatments with such medications during the screening period.

- Patients with an amputation on the affected foot, if it impedes proper offloading of the target DFU.

- Patients with active Charcot foot, or inactive Charcot foot, if it impedes proper offloading of the target DFU.

- Women who are pregnant or considering becoming pregnant within the next 6 months.

- Patients with concurrent severe psychiatric disease that in the opinion of the investigator would impede participation in the trial.

- Presence of subject having recent or current alcohol or drug abuse.

- Patients with severe kidney disease who are currently untreated or awaiting dialysis treatment

- Participation in another study involving treatment with an investigational product within the previous 30 days.

- Any other medical or psychological conditions that, in the opinion of the Investigator may make patient's participation unreliable or may interfere with study assessments.

- Patients with history of radiation to the ulcer

Study Design


Intervention

Device:
Remote Ischemic conditioning (RIC)
Intervention Group: Patients will self-administer RIC treatment with the LifeCuff device 3 times a week. Treatment will be delivered at the patient's home and compliance will be monitored by the LifeCuff device. Control Group: Patients undergo typical standard of care treatment. Assessment of Ulcer Closure: Ulcers will be assessed as completely closed by the Principal Investigator through clinical judgement and photographic support. Patients that completely heal their ulcer during the healing period will complete the study and no further blood or tissue measurements will be taken

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Des Moines University Iowa State University

Outcome

Type Measure Description Time frame Safety issue
Primary Change in ulcer area and overall healing rate Will evaluate healing rates and times for both treatment group and standard of care group using app that can take picture and measure area will be evaluated at 0, 3, 6, 9 and 12 weeks
Secondary VEGF Will evaluate blood levels of VEGF in treatment group and standard of care group will be evaluated at 0, 3, 6, 9 and 12 weeks
Secondary SDF1a Will evaluate blood levels of SDF1a in treatment group and standard of care group will be evaluated at 0, 3, 6, 9 and 12 weeks
Secondary CD34+ Will evaluate soft tissue biopsy for presence or absence of CD34+ in treatment group and standard of care group will be evaluated at 0, 3, 6, 9 and 12 weeks
Secondary tissue perfusion Will evaluate overall tissue perfusion using Laser Speckle imaging for both treatment group and standard of care group will be evaluated at 0, 3, 6, 9 and 12 weeks
See also
  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
Completed NCT01951768 - Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer Infection Phase 4
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 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 - TheraGauzeā„¢ Alone and Regranex®Gel 0.01% Plus TheraGauzeā„¢ 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