Allogenic Dermis Versus Standard Care in the Management of Diabetic Foot Ulcers

NCT02331147 | Completed

• 1 other identifier: 20142081
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief Summary

This is comparison trial comparing human dermis to standard wound care for non healing diabetic wound

Conditions

Diabetic; Foot Ulcers

Outcome Measures

Primary Outcomes (1)

• proportion of ulcers completely healed by the allogenic dermal graft protocol of care to the standard protocol of care in the management of indolent diabetic ulcers at 6 weeks

  6 weeks

Secondary Outcomes (3)

• Compare the proportion of ulcers completely healed at 4 weeks

  4 weeks

• Compare the proportion of ulcers completely healed at 12 weeks

  12 weeks

• Mean time to healing

  12 weeks

Study Arms (2)

Standard of Care

SHAM COMPARATOR

Surgical debridement of DFU, The wound will be debrided and cleaned. Patient ulcers will be assessed and measured weekly in cm length by width. Application of collagen alginate and gauze dressing application to be changed daily by patient. Patient will practice off loading

Other: Offloading

Human Dermis

ACTIVE COMPARATOR

Application of Human Allogenic Dermis with Dressing Application, to be changed weekly. Patient would will be measured in cm length by width weekly Patient will practice Offloading. If the ulcer has not closed completely, an additional piece of Human Dermis will be applied weekly at weeks 2-11 in a similar fashion

Other: Offloading; Other: Dressing Application

Interventions

Offloading OTHER

Patient will be offloaded in a diabetic camboot after treatment

Human Dermis; Standard of Care

Dressing Application OTHER

Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.

Human Dermis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 or older.
• Patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study.
• Patient's ulcer must be diabetic in origin and larger than 1 cm2.
• Patients with Type 1 or Type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ADA).
• Ulcer must be present for a minimum of four weeks before enrollment randomization, with documented failure of conventional ulcer therapy to heal the wound.
• A two week run-in period will precede enrollment/ randomization in the trial to document the indolent nature of the wounds selected.
• Additional wounds may be present but not within 3 cm of the study wound.
• Wound must be present anatomically on the foot as defined by beginning below the malleoli of the ankle and be neuropathic in origin.
• Patient's ulcer must exhibit no clinical signs of infection.
• Serum Creatinine less than 3.0mg/dl within last six months.
• HbA1c less than or equal to 12% within last 90 days.
• Patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days:
• Dorsum transcutaneous oxygen test (TcPO2) with results ≥30mmHg,
• ABIs with results of ≥0.7 and ≤1.2, OR
• Doppler arterial waveforms, which are triphasic or biphasic at the ankle of affected leg.

You may not qualify if:

• Patients presenting with an ulcer probing to tendon, muscle, capsule or bone (UT Grade IIIA-D). A positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe.
• Patients whose index diabetic foot ulcers are greater than 25 cm2.
• Patients considered not in reasonable metabolic control, confirmed by an HbA1c greater than 12% within previous 90 days.
• Patients whose serum creatinine levels are 3.0mg/dl or greater within the last six months.
• Patients with a known history of poor compliance with medical treatments.
• Patients who have been previously randomized into this study, or are presently participating in another clinical trial.
• Patients who are currently receiving radiation therapy or chemotherapy.
• Patients with known or suspected local skin malignancy to the index diabetic ulcer.
• Patients diagnosed with autoimmune connective tissues diseases.
• Non-revascularizable surgical sites.
• Active infection at site.
• Any pathology that would limit the blood supply and compromise healing.
• Patients that have received a biomedical or topical growth factor for their wound within the previous 30 days.
• Patients who are pregnant or breast feeding.
• Patients who are taking medications that are considered immune system modulators which could affect graft incorporation.

Sponsors & Collaborators

• Musculoskeletal Transplant Foundation: lead
• Professional Education and Research Institute: collaborator

Study Sites (3)

Shenandoah Lower Extremity Research

Roanoke, Virginia, 24013, United States

Location

Professional Education and Research Institute

Roanoke, Virginia, 24016, United States

Location

Foot and Ankle Associates of Southwest VA

Salem, Virginia, 24153, United States

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Charles M Zelen, DPM

  CEO; Professional Education and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2014
• First Posted: January 6, 2015
• Study Start: December 1, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: June 1, 2022

Record last verified: 2018-01

Locations

US (3)