Clinical Trials Logo

Clinical Trial Summary

This study is a prospective, multi-center, randomized controlled trial designed to collect patient outcome data on 2 commercially available SOC dressings treatments for Diabetic Foot Wounds


Clinical Trial Description

This study is a prospective, multi-center, RCT designed to collect patient outcome data on two commercially available SOC treatments for DFUs. The trial will be single blinded in regard to wound healing assessment (another clinician, other than the investigator at each site will assess wound healing) and confirmation of wound healing will be overseen by an independent adjudication committee made up of wound care experts. The study will last twelve weeks, with a two week screening period prior to enrollment. There are two standard of care arms in the study: Arm 1: The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with bioactive resorbable glass fiber dressing, MIRRAGEN™Advanced Wound Matrix, followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent). Arm 2: The SOC therapy in this study is offloading of the DFU (CAM boots or total contact casting [TCC] if the subject's foot is too large for a CAM), appropriate sharp or surgical debridement, infection management (systemic antibiotics only in conjunction with debridement) and wound care covering with calcium alginate Fibracol dressing followed by a padded 3-layer dressing comprised of 4x4 gauze pads, soft roll and compressive wrap (DynaflexTM or equivalent). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03398538
Study type Interventional
Source ETS Wound Care, LLC
Contact
Status Completed
Phase N/A
Start date December 26, 2017
Completion date October 31, 2018

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Withdrawn NCT03675269 - Adjunctive Hyperbaric Oxygen Therapy (HBOT) for Lower Extermity Diabetic Ulcer: N/A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 NCT06278935 - Lifestyle Tailored Offloading for Diabetic Foot Ulcers N/A
Not yet recruiting NCT06437028 - Evaluating the Efficacy of Perinatal Membrane Allografts for the Treatment of 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 - 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