Evidence map›Paper›PMID 30019528›Full record

Trial reportInternational wound journal2018

Use of an aseptically processed, dehydrated human amnion and chorion membrane improves likelihood and rate of healing in chronic diabetic foot ulcers: A prospective, randomised, multi-centre clinical trial in 80 patients.

Lawrence A DiDomenico, Dennis P Orgill, Robert D Galiano, Thomas E Serena, Marissa J Carter, Jarrod P Kaufman, Nathan J Young, Allen M Jacobs, Charles M Zelen

2 registry-linked trialsOpen access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in International wound journal, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 36 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 6 pooled it
3.6field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06470087 nacompletednot on this mapstarted 2024, after this paper: background citation

A Randomized Controlled Clinical Trial Comparing High Purity Type-I Collagen-based Skin Substitute to Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers

TypeinterventionalSponsorAdichunchanagiri Institute of Medical Sciences, B G NagaraRan2024 to 2024Enrolled28ConditionsDiabetic Foot Ulcer (DFU)ArmsSOC and Type-I Collagen-based Skin Substitute, SOC and Human Amnion/Chorion Membrane
NCT07046403 nacompletednot on this mapstarted 2025, after this paper: background citation

A Multicentric Randomized Controlled Clinical Trial Comparing the Use of High Purity Type-I Collagen-Based Skin Substitute vs. Dehydrated Human Amnion/Chorion Membrane in the Treatment of Diabetic Foot Ulcers

TypeinterventionalSponsorAdichunchanagiri Institute of Medical Sciences, B G NagaraRan2025 to 2025Enrolled120ConditionsDiabetic Foot Ulcer (DFU)ArmsHigh Purity Type-I Collagen-based Skin Substitute and SOC, Dehydrated Human Amnion / Chorion Membrane and SOC
3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 6 syntheses or guidelines pooled it, 83 citations in OpenAlex.

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  15. Comparative Study of Placental Allografts with Distinct Layer Composition.International journal of molecular sciences · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 9 institutions in 1 country.

Lawrence A DiDomenicoLower Extremity Institute for Research and Therapy, Youngstown, Ohio.
Dennis P OrgillDepartment of Plastic Surgery, Brigham and Women's Hospital, Boston, Massachusetts.
Robert D GalianoDivision of Plastic Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Thomas E SerenaSerena Group, Cambridge, Massachusetts.
Marissa J CarterStrategic Solutions, Inc., Cody, Wyoming.
Jarrod P KaufmanGeneral Surgery, Premier Surgical, Brick, New Jersey.
Nathan J YoungMartinsville Research Institute, Martinsville, Virginia.
Allen M JacobsAllen M Jacobs and Associates, St. Louis, Missouri.
Charles M ZelenProfessional Education and Research Institute, Roanoke, Virginia.ORCID https://orcid.org/0000-0001-5682-7056
Brigham and Women's Hospital · USGlobal Strategic Solutions (United States) · USJacobs Institute · USNorthwestern University · USPremier Research Group · USProfessional Education and Research Institute · USSerenaGroup Research Institute · USSovah Health Martinsville · USYoungstown State University · US

Funding

Musculoskeletal Transplant Foundation 002
6 · The paper itself

Abstract

Amnion and chorion allografts have shown great promise in healing diabetic foot ulcers (DFUs). Results from an interim analysis of 40 patients have demonstrated the accelerated healing ability of a novel aseptically processed, dehydrated human amnion and chorion allograft (dHACA). The goal of this study was to report on the full trial results of 80 patients where dHACA was compared with standard of care (SOC) in achieving wound closure in non-healing DFUs. After a 2-week screening period, during which patients with DFUs were unsuccessfully treated with SOC, patients were randomised to either SOC alone or SOC with dHACA applied weekly for up to 12 weeks. At 12 weeks, 85% (34/40) of the dHACA-treated DFUs healed, compared with 33% (13/40) treated with SOC alone. Mean time to heal within 12 weeks was significantly faster for the dHACA- treated group compared with SOC, 37 days vs 67 days in the SOC group (P = .000006). Mean number of grafts used per healed wound during the same time period was 4.0, and mean cost of the tissue to heal a DFU was $1771. The authors concluded that aseptically processed dHACA heals DFUs significantly faster than SOC at 12 weeks.

Indexed as

Standard of CareAgedAged, 80 and overAmnionChorionDiabetic FootFemaleHumansMaleMiddle AgedProspective StudiesTransplantation, HomologousTreatment OutcomeWound Healingamnion/chorion graftcomplete wound healingdiabetic foot ulcerrandomised controlled trialtime to heal

Identifiers

PMID30019528
PMCPMC7949511
OpenAlexW2883882871

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.